Trial Outcomes & Findings for A New Oral Treatment For Type II Diabetes Mellitus (NCT NCT00111800)

Last Updated: 2018-03-21

Results Overview

HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

375 participants

Primary outcome timeframe

Baseline (Week 0) and Week 12

Results posted on

2018-03-21

Participant Flow

The study was conducted from 28 April 2005 to 21 July 2006 across 94 centres from 9 countries.

A total of 375 participants received denagliptin (\[DEN\] 2.5, 7.5, 15, 30 or 45 milligram \[mg\]) or placebo which constituted the Safety Population. A total of 318 entered extension phase of study; 3 participants completed main phase but did not enter extension phase.

Participant milestones

Participant milestones
Measure	Placebo Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.	DEN 45 mg Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Period 1: Main Phase (12 Weeks) STARTED	64	61	63	66	60	61
Period 1: Main Phase (12 Weeks) COMPLETED	49	47	54	60	55	56
Period 1: Main Phase (12 Weeks) NOT COMPLETED	15	14	9	6	5	5
Period 2: Extension Phase (12 Weeks) STARTED	48	47	54	59	55	55
Period 2: Extension Phase (12 Weeks) COMPLETED	46	40	47	54	51	53
Period 2: Extension Phase (12 Weeks) NOT COMPLETED	2	7	7	5	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.	DEN 45 mg Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Period 1: Main Phase (12 Weeks) Adverse Event	5	4	0	0	1	0
Period 1: Main Phase (12 Weeks) Lost to Follow-up	1	0	2	0	0	2
Period 1: Main Phase (12 Weeks) Protocol Violation	0	2	4	2	1	1
Period 1: Main Phase (12 Weeks) Withdrawal by Subject	2	2	3	0	0	1
Period 1: Main Phase (12 Weeks) Lack of Efficacy	3	0	0	1	0	0
Period 1: Main Phase (12 Weeks) Insufficient therapeutic effect	1	0	0	0	1	0
Period 1: Main Phase (12 Weeks) Not meet treatment eligibility criteria	1	1	0	1	0	0
Period 1: Main Phase (12 Weeks) Lack of glycaemic control	1	1	0	0	0	0
Period 1: Main Phase (12 Weeks) Discontinued for not receiving incentive	1	0	0	0	0	0
Period 1: Main Phase (12 Weeks) Would have been a drop out at Visit 4	0	1	0	0	0	0
Period 1: Main Phase (12 Weeks) Fasting plasma glucose (FPG) below 140	0	1	0	0	0	0
Period 1: Main Phase (12 Weeks) Elevated triglycerides	0	1	0	0	0	0
Period 1: Main Phase (12 Weeks) Decrease in hemoglobin and hematocrit	0	1	0	0	0	0
Period 1: Main Phase (12 Weeks) Other-Protocol violator	0	0	0	1	0	0
Period 1: Main Phase (12 Weeks) Participant went on extended holiday	0	0	0	1	0	0
Period 1: Main Phase (12 Weeks) Participant's study medication stolen	0	0	0	0	1	0
Period 1: Main Phase (12 Weeks) Participant moved out of area	0	0	0	0	1	0
Period 1: Main Phase (12 Weeks) Sponsor requested withdrawal	0	0	0	0	0	1
Period 2: Extension Phase (12 Weeks) Adverse Event	0	2	1	3	0	0
Period 2: Extension Phase (12 Weeks) Protocol Violation	0	1	1	0	0	0
Period 2: Extension Phase (12 Weeks) Withdrawal by Subject	0	2	2	0	3	0
Period 2: Extension Phase (12 Weeks) Lack of Efficacy	1	0	1	1	0	1
Period 2: Extension Phase (12 Weeks) Insufficient therapeutic effect	1	1	0	1	1	1
Period 2: Extension Phase (12 Weeks) Lack of Glycaemic Control	0	1	0	0	0	0
Period 2: Extension Phase (12 Weeks) Electrocardiogram (ECG) results	0	0	1	0	0	0
Period 2: Extension Phase (12 Weeks) Participant received metformin	0	0	1	0	0	0

Baseline Characteristics

A New Oral Treatment For Type II Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Total n=375 Participants Total of all reporting groups
Age, Continuous	60.8 Years STANDARD_DEVIATION 10.89 • n=93 Participants	58.6 Years STANDARD_DEVIATION 9.54 • n=4 Participants	60.4 Years STANDARD_DEVIATION 12.41 • n=27 Participants	59.9 Years STANDARD_DEVIATION 7.97 • n=483 Participants	58.8 Years STANDARD_DEVIATION 9.95 • n=36 Participants	59.2 Years STANDARD_DEVIATION 7.85 • n=10 Participants	59.6 Years STANDARD_DEVIATION 9.87 • n=115 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	31 Participants n=4 Participants	32 Participants n=27 Participants	33 Participants n=483 Participants	31 Participants n=36 Participants	32 Participants n=10 Participants	191 Participants n=115 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	30 Participants n=4 Participants	31 Participants n=27 Participants	33 Participants n=483 Participants	29 Participants n=36 Participants	29 Participants n=10 Participants	184 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	6 Participants n=36 Participants	2 Participants n=10 Participants	12 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants	20 Participants n=115 Participants
Race (NIH/OMB) White	57 Participants n=93 Participants	58 Participants n=4 Participants	57 Participants n=27 Participants	60 Participants n=483 Participants	53 Participants n=36 Participants	55 Participants n=10 Participants	340 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Intent-to Treat (ITT) Population was defined as all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=58 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=59 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=56 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=59 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=62 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=56 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	-0.38 Percentage of HbA1c Standard Error 0.105	0.46 Percentage of HbA1c Standard Error 0.105	0.18 Percentage of HbA1c Standard Error 0.107	-0.07 Percentage of HbA1c Standard Error 0.104	0.01 Percentage of HbA1c Standard Error 0.102	-0.34 Percentage of HbA1c Standard Error 0.107

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Week 4	-0.32 Percentage of HbA1c Standard Deviation 0.445	0.22 Percentage of HbA1c Standard Deviation 0.672	-0.01 Percentage of HbA1c Standard Deviation 0.505	-0.11 Percentage of HbA1c Standard Deviation 0.586	-0.05 Percentage of HbA1c Standard Deviation 0.474	-0.25 Percentage of HbA1c Standard Deviation 0.436
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Week 8	-0.41 Percentage of HbA1c Standard Deviation 0.579	0.21 Percentage of HbA1c Standard Deviation 1.019	0.13 Percentage of HbA1c Standard Deviation 0.753	-0.04 Percentage of HbA1c Standard Deviation 0.789	-0.04 Percentage of HbA1c Standard Deviation 0.645	-0.36 Percentage of HbA1c Standard Deviation 0.653
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Week 16	-0.36 Percentage of HbA1c Standard Deviation 0.821	0.40 Percentage of HbA1c Standard Deviation 1.146	0.14 Percentage of HbA1c Standard Deviation 0.934	-0.04 Percentage of HbA1c Standard Deviation 0.926	0.05 Percentage of HbA1c Standard Deviation 0.790	-0.30 Percentage of HbA1c Standard Deviation 0.968
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Week 20	-0.35 Percentage of HbA1c Standard Deviation 0.823	0.31 Percentage of HbA1c Standard Deviation 1.171	0.22 Percentage of HbA1c Standard Deviation 1.143	0.02 Percentage of HbA1c Standard Deviation 1.032	0.12 Percentage of HbA1c Standard Deviation 0.853	-0.25 Percentage of HbA1c Standard Deviation 0.960
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Week 24	-0.30 Percentage of HbA1c Standard Deviation 0.900	0.35 Percentage of HbA1c Standard Deviation 1.252	0.21 Percentage of HbA1c Standard Deviation 1.184	0.06 Percentage of HbA1c Standard Deviation 1.095	0.16 Percentage of HbA1c Standard Deviation 0.942	-0.28 Percentage of HbA1c Standard Deviation 0.994

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=58 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in FPG at Week 12	-0.71 Millimole per liter (mmol/L) Standard Error 0.276	0.52 Millimole per liter (mmol/L) Standard Error 0.273	0.11 Millimole per liter (mmol/L) Standard Error 0.282	-0.28 Millimole per liter (mmol/L) Standard Error 0.272	-0.07 Millimole per liter (mmol/L) Standard Error 0.270	-0.95 Millimole per liter (mmol/L) Standard Error 0.281

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 1	-0.71 mmol/L Standard Deviation 1.605	0.33 mmol/L Standard Deviation 1.247	0.18 mmol/L Standard Deviation 2.178	-0.45 mmol/L Standard Deviation 1.462	-0.11 mmol/L Standard Deviation 1.782	-0.73 mmol/L Standard Deviation 1.088
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 2	-0.69 mmol/L Standard Deviation 2.043	0.35 mmol/L Standard Deviation 1.385	0.23 mmol/L Standard Deviation 2.113	-0.30 mmol/L Standard Deviation 1.575	-0.25 mmol/L Standard Deviation 1.460	-0.66 mmol/L Standard Deviation 1.514
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 3	-0.89 mmol/L Standard Deviation 1.844	0.37 mmol/L Standard Deviation 1.442	0.19 mmol/L Standard Deviation 1.975	-0.65 mmol/L Standard Deviation 1.814	-0.28 mmol/L Standard Deviation 1.603	-0.81 mmol/L Standard Deviation 1.591
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 4	-1.31 mmol/L Standard Deviation 1.764	0.16 mmol/L Standard Deviation 1.595	0.22 mmol/L Standard Deviation 2.005	-0.52 mmol/L Standard Deviation 2.235	-0.43 mmol/L Standard Deviation 1.548	-1.21 mmol/L Standard Deviation 1.514
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 6	-0.81 mmol/L Standard Deviation 1.882	0.17 mmol/L Standard Deviation 1.507	0.21 mmol/L Standard Deviation 2.149	-0.61 mmol/L Standard Deviation 2.139	-0.28 mmol/L Standard Deviation 1.420	-1.02 mmol/L Standard Deviation 1.657
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 8	-1.10 mmol/L Standard Deviation 1.801	0.39 mmol/L Standard Deviation 1.745	0.18 mmol/L Standard Deviation 1.996	-0.50 mmol/L Standard Deviation 2.235	-0.33 mmol/L Standard Deviation 1.593	-0.86 mmol/L Standard Deviation 1.869
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 13	-0.96 mmol/L Standard Deviation 2.058	0.25 mmol/L Standard Deviation 2.228	0.28 mmol/L Standard Deviation 2.305	-0.19 mmol/L Standard Deviation 2.226	-0.21 mmol/L Standard Deviation 2.016	-0.84 mmol/L Standard Deviation 2.175
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 14	-0.86 mmol/L Standard Deviation 2.087	0.34 mmol/L Standard Deviation 2.348	0.31 mmol/L Standard Deviation 2.444	-0.35 mmol/L Standard Deviation 2.492	-0.11 mmol/L Standard Deviation 1.821	-0.73 mmol/L Standard Deviation 2.279
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 15	-0.89 mmol/L Standard Deviation 1.952	0.16 mmol/L Standard Deviation 1.906	0.34 mmol/L Standard Deviation 2.206	-0.40 mmol/L Standard Deviation 2.334	-0.29 mmol/L Standard Deviation 1.828	-0.88 mmol/L Standard Deviation 1.904
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 16	-0.89 mmol/L Standard Deviation 2.121	0.16 mmol/L Standard Deviation 1.950	0.07 mmol/L Standard Deviation 2.381	-0.25 mmol/L Standard Deviation 2.514	-0.41 mmol/L Standard Deviation 1.910	-0.98 mmol/L Standard Deviation 2.213
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 20	-0.81 mmol/L Standard Deviation 2.344	0.16 mmol/L Standard Deviation 1.934	0.39 mmol/L Standard Deviation 2.898	-0.04 mmol/L Standard Deviation 2.549	0.09 mmol/L Standard Deviation 1.913	-1.04 mmol/L Standard Deviation 2.038
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Week 24	-0.60 mmol/L Standard Deviation 2.364	0.67 mmol/L Standard Deviation 2.543	0.53 mmol/L Standard Deviation 2.807	-0.07 mmol/L Standard Deviation 3.003	0.22 mmol/L Standard Deviation 2.186	-1.01 mmol/L Standard Deviation 2.122

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of \<=6.5%, \<7% and HbA1c reduction of \>=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=58 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=59 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=56 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=59 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=62 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=56 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants Who Were HbA1c Responders at Week 12 HbA1c <=6.5%	8 Participants	6 Participants	4 Participants	4 Participants	5 Participants	9 Participants
Number of Participants Who Were HbA1c Responders at Week 12 HbA1c <7%	14 Participants	11 Participants	9 Participants	12 Participants	9 Participants	14 Participants
Number of Participants Who Were HbA1c Responders at Week 12 HbA1c reduction >=0.7%	17 Participants	10 Participants	6 Participants	14 Participants	10 Participants	21 Participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of \<7 mmol/L and FPG reduction value of \>=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=58 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants of FPG Responders at Week 12 FPG <7 mmol/L	9 Participants	5 Participants	8 Participants	9 Participants	4 Participants	6 Participants
Number of Participants of FPG Responders at Week 12 FPG reduction >=1.7 mmol/L	18 Participants	8 Participants	12 Participants	13 Participants	10 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=58 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=55 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=53 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=61 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=62 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=57 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Fructosamine at Week 12	-19.0 Micromole (µmol/L) Standard Error 5.29	19.9 Micromole (µmol/L) Standard Error 5.44	5.0 Micromole (µmol/L) Standard Error 5.55	-2.5 Micromole (µmol/L) Standard Error 5.16	-9.3 Micromole (µmol/L) Standard Error 5.12	-19.7 Micromole (µmol/L) Standard Error 5.34

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Week 24	-10.9 µmol/L Standard Deviation 41.81	11.6 µmol/L Standard Deviation 56.07	6.7 µmol/L Standard Deviation 53.75	7.1 µmol/L Standard Deviation 49.03	7.0 µmol/L Standard Deviation 47.77	-11.0 µmol/L Standard Deviation 48.02
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Week 4	-22.0 µmol/L Standard Deviation 36.58	10.3 µmol/L Standard Deviation 38.09	-4.3 µmol/L Standard Deviation 37.01	-2.9 µmol/L Standard Deviation 34.08	-10.1 µmol/L Standard Deviation 33.64	-14.8 µmol/L Standard Deviation 29.36
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Week 8	-23.6 µmol/L Standard Deviation 33.32	15.9 µmol/L Standard Deviation 49.33	-2.1 µmol/L Standard Deviation 39.42	-5.0 µmol/L Standard Deviation 31.93	-7.7 µmol/L Standard Deviation 32.84	-20.2 µmol/L Standard Deviation 34.06
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Week 16	-18.6 µmol/L Standard Deviation 39.53	8.2 µmol/L Standard Deviation 48.67	-0.5 µmol/L Standard Deviation 48.06	-3.0 µmol/L Standard Deviation 39.37	-3.5 µmol/L Standard Deviation 45.02	-12.8 µmol/L Standard Deviation 43.62
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Week 20	-17.3 µmol/L Standard Deviation 42.07	14.7 µmol/L Standard Deviation 54.10	3.3 µmol/L Standard Deviation 51.12	0.3 µmol/L Standard Deviation 39.36	-2.0 µmol/L Standard Deviation 46.96	-9.6 µmol/L Standard Deviation 47.49

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 Fasting serum insulin	10.70 Picomole (pmol)/L Standard Error 8.641	-2.04 Picomole (pmol)/L Standard Error 8.514	-10.55 Picomole (pmol)/L Standard Error 8.804	12.14 Picomole (pmol)/L Standard Error 8.355	5.27 Picomole (pmol)/L Standard Error 8.057	3.23 Picomole (pmol)/L Standard Error 8.732
Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 Pro-insulin	-1.53 Picomole (pmol)/L Standard Error 2.307	-4.28 Picomole (pmol)/L Standard Error 2.332	-0.97 Picomole (pmol)/L Standard Error 2.418	-1.21 Picomole (pmol)/L Standard Error 2.248	-4.63 Picomole (pmol)/L Standard Error 2.228	-6.49 Picomole (pmol)/L Standard Error 2.348

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 4, Fasting serum insulin	7.23 pmol/L Standard Deviation 96.413	5.97 pmol/L Standard Deviation 50.769	-3.83 pmol/L Standard Deviation 86.792	2.85 pmol/L Standard Deviation 75.790	1.67 pmol/L Standard Deviation 55.221	21.80 pmol/L Standard Deviation 78.596
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 8, Fasting serum insulin	25.21 pmol/L Standard Deviation 246.250	1.10 pmol/L Standard Deviation 42.239	-11.90 pmol/L Standard Deviation 81.300	5.12 pmol/L Standard Deviation 81.860	2.29 pmol/L Standard Deviation 44.507	24.27 pmol/L Standard Deviation 72.846
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 16, Fasting serum insulin	9.83 pmol/L Standard Deviation 108.783	3.96 pmol/L Standard Deviation 55.879	-9.02 pmol/L Standard Deviation 87.664	20.68 pmol/L Standard Deviation 148.343	1.05 pmol/L Standard Deviation 56.293	11.11 pmol/L Standard Deviation 33.429
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 20, Fasting serum insulin	0.68 pmol/L Standard Deviation 50.704	9.89 pmol/L Standard Deviation 73.956	-0.65 pmol/L Standard Deviation 96.114	22.79 pmol/L Standard Deviation 148.597	4.76 pmol/L Standard Deviation 57.217	11.56 pmol/L Standard Deviation 41.611
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 24, Fasting serum insulin	0.69 pmol/L Standard Deviation 61.090	6.35 pmol/L Standard Deviation 55.319	-6.66 pmol/L Standard Deviation 85.054	23.47 pmol/L Standard Deviation 157.791	11.62 pmol/L Standard Deviation 73.917	8.07 pmol/L Standard Deviation 36.118
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 4, Pro-insulin	-5.55 pmol/L Standard Deviation 20.885	-1.36 pmol/L Standard Deviation 21.662	-2.42 pmol/L Standard Deviation 15.774	-1.38 pmol/L Standard Deviation 24.872	-4.48 pmol/L Standard Deviation 19.604	-4.33 pmol/L Standard Deviation 18.011
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Week 8, Pro-insulin	-4.45 pmol/L Standard Deviation 26.313	0.00 pmol/L Standard Deviation 18.948	-4.23 pmol/L Standard Deviation 16.204	-3.48 pmol/L Standard Deviation 16.865	-4.59 pmol/L Standard Deviation 18.539	-3.88 pmol/L Standard Deviation 18.139

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: ITT Population without LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Pro-insulin at Week 16, 20 and 24. Week 16	-1.35 pmol/L Standard Deviation 33.282	-2.32 pmol/L Standard Deviation 19.820	-4.45 pmol/L Standard Deviation 20.161	-3.27 pmol/L Standard Deviation 16.672	-4.24 pmol/L Standard Deviation 25.786	-4.67 pmol/L Standard Deviation 13.882
Change From Baseline in Pro-insulin at Week 16, 20 and 24. Week 20	-2.23 pmol/L Standard Deviation 22.270	-2.52 pmol/L Standard Deviation 11.898	1.11 pmol/L Standard Deviation 26.455	-2.24 pmol/L Standard Deviation 17.156	-4.95 pmol/L Standard Deviation 17.947	-4.84 pmol/L Standard Deviation 20.063
Change From Baseline in Pro-insulin at Week 16, 20 and 24. Week 24	-2.34 pmol/L Standard Deviation 22.484	-3.61 pmol/L Standard Deviation 15.914	-0.64 pmol/L Standard Deviation 21.485	-0.65 pmol/L Standard Deviation 31.694	-3.07 pmol/L Standard Deviation 23.950	-4.47 pmol/L Standard Deviation 20.598

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=54 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=56 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=52 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=58 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=62 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=52 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Pro-insulin to Insulin Ratio at Week 12	-0.06 Ratio Standard Error 0.018	-0.02 Ratio Standard Error 0.018	0.01 Ratio Standard Error 0.019	-0.04 Ratio Standard Error 0.018	-0.06 Ratio Standard Error 0.017	-0.08 Ratio Standard Error 0.018

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 4 and 8

Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.

The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=59 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=58 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 Week 4	-0.05 Ratio Standard Deviation 0.137	-0.02 Ratio Standard Deviation 0.197	-0.03 Ratio Standard Deviation 0.176	-0.03 Ratio Standard Deviation 0.137	-0.07 Ratio Standard Deviation 0.169	-0.13 Ratio Standard Deviation 0.146
Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 Week 8	-0.07 Ratio Standard Deviation 0.150	0.02 Ratio Standard Deviation 0.133	-0.01 Ratio Standard Deviation 0.229	-0.05 Ratio Standard Deviation 0.120	-0.07 Ratio Standard Deviation 0.177	-0.11 Ratio Standard Deviation 0.174

SECONDARY outcome

Timeframe: Up to Week 25

Population: Safety population was defined as all participants who received at least one dose of study medication.

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia Any SAE	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants	4 Participants
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia Any AE	30 Participants	28 Participants	26 Participants	31 Participants	36 Participants	29 Participants
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia Any event of hypoglycaemia	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 25

Population: Safety Population.

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe AE-Mild	14 Participants	16 Participants	7 Participants	21 Participants	14 Participants	9 Participants
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe AE-Moderate	11 Participants	12 Participants	14 Participants	9 Participants	21 Participants	17 Participants
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe AE-Severe	5 Participants	0 Participants	5 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe Hypoglycaemia-Mild	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe Hypoglycaemia-Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe Hypoglycaemia-Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline \>30 beats per minute (bpm) and \<50 or \>120 bpm; SBP increase or decrease from Baseline \>30 millimeter of mercury (mmHg) in the same posture and \>170 or \<100 mmHg; increase or decrease from Baseline \>20 mmHg in same posture and \>110 or \<50 mmHg.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=60 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=59 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy SBP, High	6 Participants	4 Participants	4 Participants	1 Participants	5 Participants	4 Participants
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy SBP, Low	1 Participants	4 Participants	3 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy DBP, High	2 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy DBP, Low	3 Participants	3 Participants	3 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy HR, High	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy HR, Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Body Weight Over Time Week -5	0.63 Kilogram (kg) Standard Deviation 1.808	1.09 Kilogram (kg) Standard Deviation 2.138	0.94 Kilogram (kg) Standard Deviation 1.923	0.52 Kilogram (kg) Standard Deviation 1.321	0.53 Kilogram (kg) Standard Deviation 1.740	1.24 Kilogram (kg) Standard Deviation 1.922
Change From Baseline in Body Weight Over Time Week -4	0.58 Kilogram (kg) Standard Deviation 1.329	0.64 Kilogram (kg) Standard Deviation 1.624	0.83 Kilogram (kg) Standard Deviation 1.625	0.25 Kilogram (kg) Standard Deviation 1.178	0.23 Kilogram (kg) Standard Deviation 1.396	0.79 Kilogram (kg) Standard Deviation 1.676
Change From Baseline in Body Weight Over Time Week -2	0.20 Kilogram (kg) Standard Deviation 0.894	0.31 Kilogram (kg) Standard Deviation 1.680	0.64 Kilogram (kg) Standard Deviation 1.175	0.12 Kilogram (kg) Standard Deviation 0.895	0.01 Kilogram (kg) Standard Deviation 1.167	0.35 Kilogram (kg) Standard Deviation 1.529
Change From Baseline in Body Weight Over Time Week 1	0.09 Kilogram (kg) Standard Deviation 1.023	-0.06 Kilogram (kg) Standard Deviation 1.547	-0.10 Kilogram (kg) Standard Deviation 0.927	-0.06 Kilogram (kg) Standard Deviation 0.928	0.10 Kilogram (kg) Standard Deviation 0.818	0.22 Kilogram (kg) Standard Deviation 1.396
Change From Baseline in Body Weight Over Time Week 2	-0.21 Kilogram (kg) Standard Deviation 1.264	-0.25 Kilogram (kg) Standard Deviation 1.687	0.05 Kilogram (kg) Standard Deviation 1.935	-0.26 Kilogram (kg) Standard Deviation 1.085	-0.24 Kilogram (kg) Standard Deviation 1.060	-0.34 Kilogram (kg) Standard Deviation 2.253
Change From Baseline in Body Weight Over Time Week 3	-0.21 Kilogram (kg) Standard Deviation 1.625	-0.25 Kilogram (kg) Standard Deviation 1.724	-0.38 Kilogram (kg) Standard Deviation 1.458	-0.32 Kilogram (kg) Standard Deviation 1.135	-0.25 Kilogram (kg) Standard Deviation 1.266	-0.31 Kilogram (kg) Standard Deviation 1.364
Change From Baseline in Body Weight Over Time Week 4	0.10 Kilogram (kg) Standard Deviation 1.722	-0.22 Kilogram (kg) Standard Deviation 1.761	-0.47 Kilogram (kg) Standard Deviation 1.730	-0.42 Kilogram (kg) Standard Deviation 1.210	-0.28 Kilogram (kg) Standard Deviation 1.386	-0.60 Kilogram (kg) Standard Deviation 1.448
Change From Baseline in Body Weight Over Time Week 6	-0.29 Kilogram (kg) Standard Deviation 2.285	-0.47 Kilogram (kg) Standard Deviation 1.394	-0.65 Kilogram (kg) Standard Deviation 2.413	-0.34 Kilogram (kg) Standard Deviation 1.413	-0.30 Kilogram (kg) Standard Deviation 1.601	-0.68 Kilogram (kg) Standard Deviation 2.070
Change From Baseline in Body Weight Over Time Week 8	-0.48 Kilogram (kg) Standard Deviation 2.435	-0.42 Kilogram (kg) Standard Deviation 2.023	-0.82 Kilogram (kg) Standard Deviation 2.743	-0.38 Kilogram (kg) Standard Deviation 1.817	-0.25 Kilogram (kg) Standard Deviation 1.450	-0.56 Kilogram (kg) Standard Deviation 2.213
Change From Baseline in Body Weight Over Time Week 12	-0.50 Kilogram (kg) Standard Deviation 2.422	-0.78 Kilogram (kg) Standard Deviation 2.332	-0.96 Kilogram (kg) Standard Deviation 2.869	-0.71 Kilogram (kg) Standard Deviation 1.885	-0.36 Kilogram (kg) Standard Deviation 2.009	-0.51 Kilogram (kg) Standard Deviation 2.745
Change From Baseline in Body Weight Over Time Week 13	-0.26 Kilogram (kg) Standard Deviation 2.617	-0.93 Kilogram (kg) Standard Deviation 2.435	-1.01 Kilogram (kg) Standard Deviation 3.105	-0.68 Kilogram (kg) Standard Deviation 1.988	-0.20 Kilogram (kg) Standard Deviation 1.971	-0.35 Kilogram (kg) Standard Deviation 2.761
Change From Baseline in Body Weight Over Time Week 14	-0.46 Kilogram (kg) Standard Deviation 2.513	-0.87 Kilogram (kg) Standard Deviation 2.279	-1.13 Kilogram (kg) Standard Deviation 3.304	-0.52 Kilogram (kg) Standard Deviation 2.012	-0.06 Kilogram (kg) Standard Deviation 2.060	-0.11 Kilogram (kg) Standard Deviation 2.781
Change From Baseline in Body Weight Over Time Week 15	-0.31 Kilogram (kg) Standard Deviation 2.587	-1.06 Kilogram (kg) Standard Deviation 2.540	-1.34 Kilogram (kg) Standard Deviation 3.019	-0.72 Kilogram (kg) Standard Deviation 2.072	-0.05 Kilogram (kg) Standard Deviation 2.186	-0.24 Kilogram (kg) Standard Deviation 2.991
Change From Baseline in Body Weight Over Time Week 16	-0.45 Kilogram (kg) Standard Deviation 2.471	-0.86 Kilogram (kg) Standard Deviation 2.836	-1.36 Kilogram (kg) Standard Deviation 3.222	-0.56 Kilogram (kg) Standard Deviation 1.920	-0.31 Kilogram (kg) Standard Deviation 2.428	-0.56 Kilogram (kg) Standard Deviation 3.144
Change From Baseline in Body Weight Over Time Week 20	-0.49 Kilogram (kg) Standard Deviation 2.628	-0.89 Kilogram (kg) Standard Deviation 3.002	-1.42 Kilogram (kg) Standard Deviation 3.604	-0.59 Kilogram (kg) Standard Deviation 2.225	-0.07 Kilogram (kg) Standard Deviation 2.666	-0.30 Kilogram (kg) Standard Deviation 3.275
Change From Baseline in Body Weight Over Time Week 24	-0.43 Kilogram (kg) Standard Deviation 2.879	-1.35 Kilogram (kg) Standard Deviation 3.343	-1.86 Kilogram (kg) Standard Deviation 3.996	-0.24 Kilogram (kg) Standard Deviation 2.185	-0.31 Kilogram (kg) Standard Deviation 3.195	-0.82 Kilogram (kg) Standard Deviation 3.517
Change From Baseline in Body Weight Over Time Week 25	-0.33 Kilogram (kg) Standard Deviation 2.892	-0.97 Kilogram (kg) Standard Deviation 3.207	-1.56 Kilogram (kg) Standard Deviation 3.558	-0.45 Kilogram (kg) Standard Deviation 2.264	-0.13 Kilogram (kg) Standard Deviation 3.048	-0.65 Kilogram (kg) Standard Deviation 3.492

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Body Mass Index (BMI) Over Time Week -5	0.239 kg/meter square (m^2) Standard Deviation 0.7085	0.374 kg/meter square (m^2) Standard Deviation 0.7989	0.392 kg/meter square (m^2) Standard Deviation 0.7566	0.183 kg/meter square (m^2) Standard Deviation 0.6269	0.207 kg/meter square (m^2) Standard Deviation 0.6319	0.538 kg/meter square (m^2) Standard Deviation 0.8620
Change From Baseline in Body Mass Index (BMI) Over Time Week -4	0.228 kg/meter square (m^2) Standard Deviation 0.5114	0.233 kg/meter square (m^2) Standard Deviation 0.6648	0.353 kg/meter square (m^2) Standard Deviation 0.7561	0.098 kg/meter square (m^2) Standard Deviation 0.5932	0.102 kg/meter square (m^2) Standard Deviation 0.5311	0.393 kg/meter square (m^2) Standard Deviation 0.8380
Change From Baseline in Body Mass Index (BMI) Over Time Week -2	0.090 kg/meter square (m^2) Standard Deviation 0.3338	0.108 kg/meter square (m^2) Standard Deviation 0.6859	0.292 kg/meter square (m^2) Standard Deviation 0.6340	0.029 kg/meter square (m^2) Standard Deviation 0.4579	0.015 kg/meter square (m^2) Standard Deviation 0.4473	0.231 kg/meter square (m^2) Standard Deviation 0.8162
Change From Baseline in Body Mass Index (BMI) Over Time Week 1	0.030 kg/meter square (m^2) Standard Deviation 0.3405	-0.025 kg/meter square (m^2) Standard Deviation 0.5418	-0.037 kg/meter square (m^2) Standard Deviation 0.3218	-0.025 kg/meter square (m^2) Standard Deviation 0.3264	0.032 kg/meter square (m^2) Standard Deviation 0.2852	0.057 kg/meter square (m^2) Standard Deviation 0.4327
Change From Baseline in Body Mass Index (BMI) Over Time Week 2	-0.077 kg/meter square (m^2) Standard Deviation 0.4441	-0.091 kg/meter square (m^2) Standard Deviation 0.5994	0.015 kg/meter square (m^2) Standard Deviation 0.6716	-0.089 kg/meter square (m^2) Standard Deviation 0.3943	-0.091 kg/meter square (m^2) Standard Deviation 0.3694	-0.130 kg/meter square (m^2) Standard Deviation 0.7748
Change From Baseline in Body Mass Index (BMI) Over Time Week 3	-0.069 kg/meter square (m^2) Standard Deviation 0.5451	-0.090 kg/meter square (m^2) Standard Deviation 0.6028	-0.131 kg/meter square (m^2) Standard Deviation 0.4948	-0.111 kg/meter square (m^2) Standard Deviation 0.3975	-0.095 kg/meter square (m^2) Standard Deviation 0.4416	-0.112 kg/meter square (m^2) Standard Deviation 0.4597
Change From Baseline in Body Mass Index (BMI) Over Time Week 4	0.035 kg/meter square (m^2) Standard Deviation 0.6149	-0.076 kg/meter square (m^2) Standard Deviation 0.6281	-0.169 kg/meter square (m^2) Standard Deviation 0.5870	-0.140 kg/meter square (m^2) Standard Deviation 0.4301	-0.094 kg/meter square (m^2) Standard Deviation 0.4858	-0.218 kg/meter square (m^2) Standard Deviation 0.5059
Change From Baseline in Body Mass Index (BMI) Over Time Week 6	-0.103 kg/meter square (m^2) Standard Deviation 0.8156	-0.165 kg/meter square (m^2) Standard Deviation 0.4784	-0.237 kg/meter square (m^2) Standard Deviation 0.8112	-0.118 kg/meter square (m^2) Standard Deviation 0.5153	-0.107 kg/meter square (m^2) Standard Deviation 0.5504	-0.243 kg/meter square (m^2) Standard Deviation 0.7277
Change From Baseline in Body Mass Index (BMI) Over Time Week 8	-0.173 kg/meter square (m^2) Standard Deviation 0.8603	-0.158 kg/meter square (m^2) Standard Deviation 0.7015	-0.303 kg/meter square (m^2) Standard Deviation 0.9424	-0.128 kg/meter square (m^2) Standard Deviation 0.6772	-0.080 kg/meter square (m^2) Standard Deviation 0.4984	-0.211 kg/meter square (m^2) Standard Deviation 0.7819
Change From Baseline in Body Mass Index (BMI) Over Time Week 12	-0.179 kg/meter square (m^2) Standard Deviation 0.8777	-0.282 kg/meter square (m^2) Standard Deviation 0.8331	-0.356 kg/meter square (m^2) Standard Deviation 0.9912	-0.247 kg/meter square (m^2) Standard Deviation 0.6796	-0.127 kg/meter square (m^2) Standard Deviation 0.7081	-0.195 kg/meter square (m^2) Standard Deviation 0.9608
Change From Baseline in Body Mass Index (BMI) Over Time Week 13	-0.083 kg/meter square (m^2) Standard Deviation 0.9680	-0.324 kg/meter square (m^2) Standard Deviation 0.8814	-0.377 kg/meter square (m^2) Standard Deviation 1.0859	-0.238 kg/meter square (m^2) Standard Deviation 0.7310	-0.064 kg/meter square (m^2) Standard Deviation 0.6939	-0.157 kg/meter square (m^2) Standard Deviation 1.0077
Change From Baseline in Body Mass Index (BMI) Over Time Week 14	-0.150 kg/meter square (m^2) Standard Deviation 0.9222	-0.311 kg/meter square (m^2) Standard Deviation 0.7919	-0.421 kg/meter square (m^2) Standard Deviation 1.1495	-0.189 kg/meter square (m^2) Standard Deviation 0.7403	-0.014 kg/meter square (m^2) Standard Deviation 0.7241	-0.074 kg/meter square (m^2) Standard Deviation 1.0056
Change From Baseline in Body Mass Index (BMI) Over Time Week 15	-0.103 kg/meter square (m^2) Standard Deviation 0.9438	-0.375 kg/meter square (m^2) Standard Deviation 0.8965	-0.485 kg/meter square (m^2) Standard Deviation 1.0575	-0.255 kg/meter square (m^2) Standard Deviation 0.7621	-0.006 kg/meter square (m^2) Standard Deviation 0.7797	-0.111 kg/meter square (m^2) Standard Deviation 1.0993
Change From Baseline in Body Mass Index (BMI) Over Time Week 16	-0.147 kg/meter square (m^2) Standard Deviation 0.8926	-0.306 kg/meter square (m^2) Standard Deviation 1.0187	-0.494 kg/meter square (m^2) Standard Deviation 1.1385	-0.200 kg/meter square (m^2) Standard Deviation 0.7002	-0.106 kg/meter square (m^2) Standard Deviation 0.8592	-0.215 kg/meter square (m^2) Standard Deviation 1.1414
Change From Baseline in Body Mass Index (BMI) Over Time Week 20	-0.171 kg/meter square (m^2) Standard Deviation 0.9598	-0.312 kg/meter square (m^2) Standard Deviation 1.0837	-0.524 kg/meter square (m^2) Standard Deviation 1.2742	-0.211 kg/meter square (m^2) Standard Deviation 0.8145	-0.015 kg/meter square (m^2) Standard Deviation 0.9340	-0.138 kg/meter square (m^2) Standard Deviation 1.1961
Change From Baseline in Body Mass Index (BMI) Over Time Week 24	-0.146 kg/meter square (m^2) Standard Deviation 1.0313	-0.494 kg/meter square (m^2) Standard Deviation 1.1899	-0.672 kg/meter square (m^2) Standard Deviation 1.4019	-0.080 kg/meter square (m^2) Standard Deviation 0.7930	-0.105 kg/meter square (m^2) Standard Deviation 1.1095	-0.341 kg/meter square (m^2) Standard Deviation 1.2751
Change From Baseline in Body Mass Index (BMI) Over Time Week 25	-0.107 kg/meter square (m^2) Standard Deviation 1.0426	-0.350 kg/meter square (m^2) Standard Deviation 1.1468	-0.571 kg/meter square (m^2) Standard Deviation 1.2553	-0.152 kg/meter square (m^2) Standard Deviation 0.8295	-0.041 kg/meter square (m^2) Standard Deviation 1.0595	-0.268 kg/meter square (m^2) Standard Deviation 1.2877

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in Waist Circumference and Hip Circumference Over Time Hip circumference, Week -5	-0.2 Centimeter (cm) Standard Deviation 4.61	-0.1 Centimeter (cm) Standard Deviation 5.55	0.0 Centimeter (cm) Standard Deviation 4.49	-0.5 Centimeter (cm) Standard Deviation 4.05	-0.3 Centimeter (cm) Standard Deviation 3.92	0.6 Centimeter (cm) Standard Deviation 5.31
Change From Baseline in Waist Circumference and Hip Circumference Over Time Hip circumference, Week 12	-2.6 Centimeter (cm) Standard Deviation 6.25	-0.4 Centimeter (cm) Standard Deviation 4.73	-0.5 Centimeter (cm) Standard Deviation 4.36	-0.2 Centimeter (cm) Standard Deviation 3.25	0.6 Centimeter (cm) Standard Deviation 3.82	-0.1 Centimeter (cm) Standard Deviation 4.77
Change From Baseline in Waist Circumference and Hip Circumference Over Time Hip circumference, Week 24	-1.1 Centimeter (cm) Standard Deviation 3.67	-1.6 Centimeter (cm) Standard Deviation 4.37	-2.7 Centimeter (cm) Standard Deviation 5.37	-0.3 Centimeter (cm) Standard Deviation 4.47	0.0 Centimeter (cm) Standard Deviation 5.11	-0.9 Centimeter (cm) Standard Deviation 6.03
Change From Baseline in Waist Circumference and Hip Circumference Over Time Waist circumference, Week -5	1.3 Centimeter (cm) Standard Deviation 6.08	1.0 Centimeter (cm) Standard Deviation 4.49	2.6 Centimeter (cm) Standard Deviation 4.19	0.9 Centimeter (cm) Standard Deviation 4.46	0.9 Centimeter (cm) Standard Deviation 5.16	-1.4 Centimeter (cm) Standard Deviation 4.97
Change From Baseline in Waist Circumference and Hip Circumference Over Time Waist circumference, Week 12	1.2 Centimeter (cm) Standard Deviation 7.60	-1.1 Centimeter (cm) Standard Deviation 4.90	-0.5 Centimeter (cm) Standard Deviation 4.47	-1.0 Centimeter (cm) Standard Deviation 3.26	-0.4 Centimeter (cm) Standard Deviation 3.39	-0.1 Centimeter (cm) Standard Deviation 4.78
Change From Baseline in Waist Circumference and Hip Circumference Over Time Waist circumference, Week 24	-0.8 Centimeter (cm) Standard Deviation 5.70	-1.9 Centimeter (cm) Standard Deviation 4.84	-1.0 Centimeter (cm) Standard Deviation 5.38	-0.9 Centimeter (cm) Standard Deviation 3.91	0.3 Centimeter (cm) Standard Deviation 4.80	-1.1 Centimeter (cm) Standard Deviation 7.13

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Mean Change From Baseline in Waist to Hip Ratio Over Time Week -5	0.01 Ratio Standard Deviation 0.086	0.01 Ratio Standard Deviation 0.086	0.02 Ratio Standard Deviation 0.063	0.01 Ratio Standard Deviation 0.063	0.01 Ratio Standard Deviation 0.067	-0.02 Ratio Standard Deviation 0.060
Mean Change From Baseline in Waist to Hip Ratio Over Time Week 12	0.03 Ratio Standard Deviation 0.109	-0.01 Ratio Standard Deviation 0.054	-0.00 Ratio Standard Deviation 0.070	-0.01 Ratio Standard Deviation 0.037	-0.01 Ratio Standard Deviation 0.047	-0.00 Ratio Standard Deviation 0.067
Mean Change From Baseline in Waist to Hip Ratio Over Time Week 24	0.00 Ratio Standard Deviation 0.051	-0.00 Ratio Standard Deviation 0.054	0.01 Ratio Standard Deviation 0.064	-0.01 Ratio Standard Deviation 0.039	0.00 Ratio Standard Deviation 0.064	-0.00 Ratio Standard Deviation 0.083

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Change From Baseline in 12-lead ECG Over Time QTcF interval, Week 4	5.0 Milliseconds (msec) Standard Deviation 13.05	-6.1 Milliseconds (msec) Standard Deviation 17.19	-4.6 Milliseconds (msec) Standard Deviation 13.17	-0.5 Milliseconds (msec) Standard Deviation 17.66	-1.8 Milliseconds (msec) Standard Deviation 13.06	2.1 Milliseconds (msec) Standard Deviation 15.11
Change From Baseline in 12-lead ECG Over Time QTcF interval, Week -5	0.2 Milliseconds (msec) Standard Deviation 15.97	-3.8 Milliseconds (msec) Standard Deviation 18.10	-3.0 Milliseconds (msec) Standard Deviation 14.83	-0.7 Milliseconds (msec) Standard Deviation 17.28	-4.4 Milliseconds (msec) Standard Deviation 13.03	-2.5 Milliseconds (msec) Standard Deviation 15.28
Change From Baseline in 12-lead ECG Over Time QTcF interval, Week 12	0.1 Milliseconds (msec) Standard Deviation 15.58	-6.7 Milliseconds (msec) Standard Deviation 18.74	-5.1 Milliseconds (msec) Standard Deviation 18.06	-1.5 Milliseconds (msec) Standard Deviation 15.42	-3.2 Milliseconds (msec) Standard Deviation 13.59	-0.1 Milliseconds (msec) Standard Deviation 13.35
Change From Baseline in 12-lead ECG Over Time QTcF interval,Week 16	0.4 Milliseconds (msec) Standard Deviation 17.38	-6.5 Milliseconds (msec) Standard Deviation 17.67	-2.2 Milliseconds (msec) Standard Deviation 17.47	0.3 Milliseconds (msec) Standard Deviation 19.10	-1.9 Milliseconds (msec) Standard Deviation 16.80	0.6 Milliseconds (msec) Standard Deviation 16.97
Change From Baseline in 12-lead ECG Over Time QTcF interval, Week 24	1.4 Milliseconds (msec) Standard Deviation 13.67	-5.0 Milliseconds (msec) Standard Deviation 17.52	-3.2 Milliseconds (msec) Standard Deviation 15.93	1.3 Milliseconds (msec) Standard Deviation 16.65	-3.8 Milliseconds (msec) Standard Deviation 18.73	0.8 Milliseconds (msec) Standard Deviation 16.16
Change From Baseline in 12-lead ECG Over Time RR interval, Week -5	9.3 Milliseconds (msec) Standard Deviation 102.60	-25.5 Milliseconds (msec) Standard Deviation 91.91	-22.7 Milliseconds (msec) Standard Deviation 107.49	-5.1 Milliseconds (msec) Standard Deviation 100.41	-9.7 Milliseconds (msec) Standard Deviation 75.09	-25.0 Milliseconds (msec) Standard Deviation 101.94
Change From Baseline in 12-lead ECG Over Time RR interval, Week 4	23.1 Milliseconds (msec) Standard Deviation 105.94	10.8 Milliseconds (msec) Standard Deviation 106.59	26.0 Milliseconds (msec) Standard Deviation 99.73	4.7 Milliseconds (msec) Standard Deviation 104.53	15.0 Milliseconds (msec) Standard Deviation 88.09	-17.5 Milliseconds (msec) Standard Deviation 97.17
Change From Baseline in 12-lead ECG Over Time RR interval, Week 12	-2.2 Milliseconds (msec) Standard Deviation 104.03	9.2 Milliseconds (msec) Standard Deviation 103.33	-5.6 Milliseconds (msec) Standard Deviation 117.39	-4.6 Milliseconds (msec) Standard Deviation 102.36	-3.1 Milliseconds (msec) Standard Deviation 118.09	-21.4 Milliseconds (msec) Standard Deviation 103.46
Change From Baseline in 12-lead ECG Over Time RR interval, Week 16	3.6 Milliseconds (msec) Standard Deviation 121.42	13.3 Milliseconds (msec) Standard Deviation 124.03	5.7 Milliseconds (msec) Standard Deviation 115.66	10.9 Milliseconds (msec) Standard Deviation 119.81	11.3 Milliseconds (msec) Standard Deviation 82.95	-24.4 Milliseconds (msec) Standard Deviation 99.46
Change From Baseline in 12-lead ECG Over Time RR interval, Week 24	17.2 Milliseconds (msec) Standard Deviation 115.09	5.9 Milliseconds (msec) Standard Deviation 109.76	-13.4 Milliseconds (msec) Standard Deviation 107.74	-1.7 Milliseconds (msec) Standard Deviation 119.94	-2.7 Milliseconds (msec) Standard Deviation 85.56	-14.6 Milliseconds (msec) Standard Deviation 97.99
Change From Baseline in 12-lead ECG Over Time PR interval, Week -5	0.4 Milliseconds (msec) Standard Deviation 14.31	-1.5 Milliseconds (msec) Standard Deviation 13.52	1.0 Milliseconds (msec) Standard Deviation 11.38	0.3 Milliseconds (msec) Standard Deviation 13.59	-0.1 Milliseconds (msec) Standard Deviation 13.16	-1.3 Milliseconds (msec) Standard Deviation 13.42
Change From Baseline in 12-lead ECG Over Time PR interval, Week 4	-3.5 Milliseconds (msec) Standard Deviation 22.94	1.4 Milliseconds (msec) Standard Deviation 13.56	0.3 Milliseconds (msec) Standard Deviation 13.03	-1.1 Milliseconds (msec) Standard Deviation 17.22	-0.3 Milliseconds (msec) Standard Deviation 14.05	0.5 Milliseconds (msec) Standard Deviation 14.18
Change From Baseline in 12-lead ECG Over Time PR interval, Week 12	-4.1 Milliseconds (msec) Standard Deviation 23.38	-0.6 Milliseconds (msec) Standard Deviation 14.18	-0.4 Milliseconds (msec) Standard Deviation 17.29	-1.4 Milliseconds (msec) Standard Deviation 14.67	1.7 Milliseconds (msec) Standard Deviation 13.56	1.1 Milliseconds (msec) Standard Deviation 14.19
Change From Baseline in 12-lead ECG Over Time PR interval, Week 16	-2.4 Milliseconds (msec) Standard Deviation 20.76	1.4 Milliseconds (msec) Standard Deviation 14.80	0.4 Milliseconds (msec) Standard Deviation 13.38	0.0 Milliseconds (msec) Standard Deviation 14.24	1.0 Milliseconds (msec) Standard Deviation 12.91	1.1 Milliseconds (msec) Standard Deviation 13.07
Change From Baseline in 12-lead ECG Over Time PR interval, Week 24	-5.5 Milliseconds (msec) Standard Deviation 21.87	-0.2 Milliseconds (msec) Standard Deviation 15.39	-0.6 Milliseconds (msec) Standard Deviation 11.79	-1.5 Milliseconds (msec) Standard Deviation 14.61	0.3 Milliseconds (msec) Standard Deviation 12.11	1.4 Milliseconds (msec) Standard Deviation 13.17
Change From Baseline in 12-lead ECG Over Time QRS duration, Week -5	1.4 Milliseconds (msec) Standard Deviation 8.65	-0.4 Milliseconds (msec) Standard Deviation 8.22	-1.4 Milliseconds (msec) Standard Deviation 7.36	2.1 Milliseconds (msec) Standard Deviation 8.21	1.0 Milliseconds (msec) Standard Deviation 10.92	-0.6 Milliseconds (msec) Standard Deviation 7.80
Change From Baseline in 12-lead ECG Over Time QRS duration, Week 4	0.8 Milliseconds (msec) Standard Deviation 8.36	-2.0 Milliseconds (msec) Standard Deviation 7.87	-0.1 Milliseconds (msec) Standard Deviation 7.84	-0.5 Milliseconds (msec) Standard Deviation 8.49	0.7 Milliseconds (msec) Standard Deviation 10.35	-0.6 Milliseconds (msec) Standard Deviation 7.40
Change From Baseline in 12-lead ECG Over Time QRS duration, Week 12	0.9 Milliseconds (msec) Standard Deviation 8.97	-1.2 Milliseconds (msec) Standard Deviation 7.26	-0.2 Milliseconds (msec) Standard Deviation 6.85	2.2 Milliseconds (msec) Standard Deviation 8.65	-0.1 Milliseconds (msec) Standard Deviation 12.10	0.1 Milliseconds (msec) Standard Deviation 7.29
Change From Baseline in 12-lead ECG Over Time QRS duration, Week 16	-0.8 Milliseconds (msec) Standard Deviation 9.39	-1.9 Milliseconds (msec) Standard Deviation 8.28	-1.4 Milliseconds (msec) Standard Deviation 7.64	0.1 Milliseconds (msec) Standard Deviation 8.68	-1.1 Milliseconds (msec) Standard Deviation 11.46	-0.5 Milliseconds (msec) Standard Deviation 7.56
Change From Baseline in 12-lead ECG Over Time QRS duration, Week 24	-1.1 Milliseconds (msec) Standard Deviation 8.33	-2.4 Milliseconds (msec) Standard Deviation 9.48	-1.3 Milliseconds (msec) Standard Deviation 8.29	1.5 Milliseconds (msec) Standard Deviation 8.29	0.0 Milliseconds (msec) Standard Deviation 12.13	0.8 Milliseconds (msec) Standard Deviation 10.09
Change From Baseline in 12-lead ECG Over Time UncQT, Week -5	1.6 Milliseconds (msec) Standard Deviation 19.27	-7.2 Milliseconds (msec) Standard Deviation 20.58	-6.6 Milliseconds (msec) Standard Deviation 21.32	-1.1 Milliseconds (msec) Standard Deviation 21.36	-5.7 Milliseconds (msec) Standard Deviation 16.47	-6.2 Milliseconds (msec) Standard Deviation 20.34
Change From Baseline in 12-lead ECG Over Time UncQT, Week 4	9.0 Milliseconds (msec) Standard Deviation 18.34	-4.7 Milliseconds (msec) Standard Deviation 22.21	-0.9 Milliseconds (msec) Standard Deviation 18.52	0.4 Milliseconds (msec) Standard Deviation 20.89	0.4 Milliseconds (msec) Standard Deviation 18.28	-0.6 Milliseconds (msec) Standard Deviation 21.32
Change From Baseline in 12-lead ECG Over Time UncQT, Week 12	0.2 Milliseconds (msec) Standard Deviation 20.74	-5.1 Milliseconds (msec) Standard Deviation 20.62	-6.7 Milliseconds (msec) Standard Deviation 21.53	-2.1 Milliseconds (msec) Standard Deviation 19.20	-3.5 Milliseconds (msec) Standard Deviation 18.34	-3.1 Milliseconds (msec) Standard Deviation 17.18
Change From Baseline in 12-lead ECG Over Time UncQT, Week 16	1.5 Milliseconds (msec) Standard Deviation 23.05	-4.6 Milliseconds (msec) Standard Deviation 23.44	-1.7 Milliseconds (msec) Standard Deviation 19.94	1.8 Milliseconds (msec) Standard Deviation 20.28	-0.3 Milliseconds (msec) Standard Deviation 20.48	-2.9 Milliseconds (msec) Standard Deviation 20.11
Change From Baseline in 12-lead ECG Over Time UncQT, Week 24	4.3 Milliseconds (msec) Standard Deviation 19.99	-4.0 Milliseconds (msec) Standard Deviation 21.76	-5.7 Milliseconds (msec) Standard Deviation 22.50	1.2 Milliseconds (msec) Standard Deviation 21.42	-4.0 Milliseconds (msec) Standard Deviation 19.52	-1.3 Milliseconds (msec) Standard Deviation 21.30
Change From Baseline in 12-lead ECG Over Time QTcB interval, Week -5	-0.7 Milliseconds (msec) Standard Deviation 19.55	-1.9 Milliseconds (msec) Standard Deviation 20.79	-0.8 Milliseconds (msec) Standard Deviation 17.21	-0.4 Milliseconds (msec) Standard Deviation 19.51	-3.6 Milliseconds (msec) Standard Deviation 14.95	-0.7 Milliseconds (msec) Standard Deviation 18.37
Change From Baseline in 12-lead ECG Over Time QTcB interval, Week 4	2.7 Milliseconds (msec) Standard Deviation 17.44	-6.8 Milliseconds (msec) Standard Deviation 19.85	-6.5 Milliseconds (msec) Standard Deviation 15.93	-1.1 Milliseconds (msec) Standard Deviation 20.65	-2.8 Milliseconds (msec) Standard Deviation 15.10	3.4 Milliseconds (msec) Standard Deviation 17.15
Change From Baseline in 12-lead ECG Over Time QTcB interval, Week 12	0.0 Milliseconds (msec) Standard Deviation 18.96	-7.7 Milliseconds (msec) Standard Deviation 22.46	-4.2 Milliseconds (msec) Standard Deviation 22.27	-1.2 Milliseconds (msec) Standard Deviation 18.28	-2.8 Milliseconds (msec) Standard Deviation 18.14	1.5 Milliseconds (msec) Standard Deviation 17.86
Change From Baseline in 12-lead ECG Over Time QTcB interval, Week 16	-0.3 Milliseconds (msec) Standard Deviation 21.13	-7.5 Milliseconds (msec) Standard Deviation 21.52	-2.1 Milliseconds (msec) Standard Deviation 22.13	-0.6 Milliseconds (msec) Standard Deviation 23.84	-2.5 Milliseconds (msec) Standard Deviation 18.14	2.4 Milliseconds (msec) Standard Deviation 20.20
Change From Baseline in 12-lead ECG Over Time QTcB interval, Week 24	-0.1 Milliseconds (msec) Standard Deviation 17.55	-5.4 Milliseconds (msec) Standard Deviation 20.82	-1.7 Milliseconds (msec) Standard Deviation 17.94	1.3 Milliseconds (msec) Standard Deviation 20.06	-3.5 Milliseconds (msec) Standard Deviation 21.66	1.9 Milliseconds (msec) Standard Deviation 17.90

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase (\[LDH\] if \>2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=60 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=59 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Albumin, High	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy AST, high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Calcium, Low	10 Participants	3 Participants	5 Participants	5 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Carbon dioxide content/bicarbonate, low	7 Participants	3 Participants	5 Participants	6 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Creatinine, high	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Glucose, low	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Phosphorus inorganic, high	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Potassium,high	10 Participants	11 Participants	4 Participants	8 Participants	7 Participants	7 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Sodium, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Sodium, low	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Total bilirubin, high	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy Uric scid, high	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population. Only those participants available at the specified time points were analyzed.

The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.

Outcome measures

Outcome measures
Measure	DEN 45 mg n=60 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=62 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=60 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=62 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=63 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=59 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy Hematocrit, high	2 Participants	3 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy Hematocrit, low	1 Participants	1 Participants	4 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy Hemoglobin, high	2 Participants	3 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy Hemoglobin, low	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy Platelet count, low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy WBC count, high	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Follow-up (Week 25)

Population: Safety Population.

The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Protein, trace	1 Participants	7 Participants	7 Participants	3 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Protein, 1+	0 Participants	3 Participants	3 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Protein, 2+	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Glucose, trace or 1/10 g/dL	3 Participants	6 Participants	7 Participants	5 Participants	9 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Glucose, 1+ or 1/4 g/dL	3 Participants	2 Participants	4 Participants	6 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Glucose, 2+ or 1/2 g/dL	1 Participants	4 Participants	5 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Glucose, 3+ or 1 g/dL	3 Participants	6 Participants	3 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Ketones, trace	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Ketones, 1+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Protein, trace	4 Participants	8 Participants	8 Participants	5 Participants	6 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Protein, 1+	1 Participants	4 Participants	3 Participants	3 Participants	5 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Protein, 2+	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 6, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Glucose, trace or 1/10 g/dL	5 Participants	6 Participants	5 Participants	5 Participants	7 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Glucose, 1+ or 1/4 g/dL	2 Participants	1 Participants	3 Participants	5 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Glucose, 2+ or 1/2 g/dL	3 Participants	2 Participants	2 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Glucose, 3+ or 1 g/dL	0 Participants	8 Participants	4 Participants	5 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Ketones, trace	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Ketones, 1+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Protein, trace	1 Participants	2 Participants	5 Participants	5 Participants	8 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Protein, 1+	2 Participants	4 Participants	4 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Protein, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 8, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Glucose, trace or 1/10 g/dL	3 Participants	6 Participants	7 Participants	7 Participants	5 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Glucose, 1+ or 1/4 g/dL	6 Participants	1 Participants	6 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Glucose, 2+ or 1/2 g/dL	2 Participants	3 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Glucose, 3+ or 1 g/dL	0 Participants	6 Participants	6 Participants	7 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Ketones, trace	1 Participants	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Ketones, 1+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Protein, trace	4 Participants	7 Participants	6 Participants	5 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Protein, 1+	0 Participants	1 Participants	5 Participants	3 Participants	4 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Protein, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 12, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Protein, 2+	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Glucose, trace or 1/10 g/dL	5 Participants	1 Participants	6 Participants	2 Participants	7 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Glucose, 1+ or 1/4 g/dL	4 Participants	2 Participants	1 Participants	1 Participants	7 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Glucose, 2+ or 1/2 g/dL	1 Participants	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Glucose, 3+ or 1 g/dL	2 Participants	7 Participants	6 Participants	6 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Ketones, trace	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Ketones, 1+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Protein, trace	3 Participants	3 Participants	6 Participants	0 Participants	4 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 13, Protein, 1+	1 Participants	2 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Glucose, trace or 1/10 g/dL	2 Participants	3 Participants	7 Participants	6 Participants	5 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Glucose, trace or 1/10 g/dL	9 Participants	7 Participants	3 Participants	6 Participants	4 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Glucose, 1+ or 1/4 g/dL	2 Participants	3 Participants	6 Participants	4 Participants	3 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Glucose, 2+ or 1/2 g/dL	4 Participants	1 Participants	1 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Glucose, 3+ or 1 g/dL	3 Participants	5 Participants	3 Participants	3 Participants	1 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Ketones, trace	2 Participants	3 Participants	2 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Ketones, 1+	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Protein, trace	3 Participants	8 Participants	4 Participants	9 Participants	5 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Protein,1+	2 Participants	6 Participants	6 Participants	5 Participants	5 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Protein, 2+	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week -5, Protein, 3+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Glucose, trace or 1/10 g/dL	6 Participants	10 Participants	5 Participants	3 Participants	5 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Glucose, 1+ or 1/4 g/dL	5 Participants	3 Participants	5 Participants	7 Participants	7 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Glucose, 2+ or 1/2 g/dL	0 Participants	5 Participants	3 Participants	3 Participants	4 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Glucose, 3+ or 1 g/dL	8 Participants	3 Participants	6 Participants	5 Participants	4 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Ketones, trace	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Protein, trace	6 Participants	9 Participants	10 Participants	5 Participants	9 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Protein,1+	2 Participants	8 Participants	2 Participants	4 Participants	4 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Protein, 2+	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 0, Protein, 3+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Glucose, trace or 1/10 g/dL	4 Participants	7 Participants	4 Participants	9 Participants	8 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Glucose, 1+ or 1/4 g/dL	2 Participants	0 Participants	5 Participants	3 Participants	3 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Glucose, 1+ or 1/4 g/dL	4 Participants	5 Participants	7 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Glucose, 2+ or 1/2 g/dL	2 Participants	4 Participants	0 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Glucose, 3+ or 1 g/dL	3 Participants	7 Participants	3 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Ketones, trace	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Glucose, 2+ or 1/2 g/dL	1 Participants	4 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Protein, trace	4 Participants	2 Participants	3 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Protein, 1+	1 Participants	3 Participants	3 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Glucose, 3+ or 1 g/dL	5 Participants	6 Participants	7 Participants	5 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Protein, 2+	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Ketones, trace	3 Participants	2 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 14, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Glucose, trace or 1/10 g/dL	4 Participants	2 Participants	5 Participants	5 Participants	4 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Glucose, 1+ or 1/4 g/dL	1 Participants	5 Participants	4 Participants	3 Participants	5 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Ketones, 1+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Glucose, 2+ or 1/2 g/dL	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Glucose, 3+ or 1 g/dL	2 Participants	6 Participants	4 Participants	5 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Ketones, trace	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Protein, trace	5 Participants	7 Participants	2 Participants	5 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Protein, 1+	2 Participants	1 Participants	2 Participants	3 Participants	4 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Protein, 2+	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 15, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Glucose, trace or 1/10 g/dL	6 Participants	7 Participants	4 Participants	4 Participants	5 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Protein, trace	4 Participants	7 Participants	7 Participants	6 Participants	4 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Glucose, 1+ or 1/4 g/dL	1 Participants	0 Participants	4 Participants	3 Participants	8 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Glucose, 2+ or 1/2 g/dL	3 Participants	2 Participants	0 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Protein,1+	0 Participants	7 Participants	6 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Protein, 2+	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 1, Protein, 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Glucose, trace or 1/10 g/dL	4 Participants	4 Participants	6 Participants	9 Participants	5 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Glucose, 1+ or 1/4 g/dL	5 Participants	1 Participants	3 Participants	2 Participants	1 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Glucose, 2+ or 1/2 g/dL	1 Participants	3 Participants	4 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Glucose, 3+ or 1 g/dL	3 Participants	7 Participants	8 Participants	6 Participants	3 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Ketones, trace	0 Participants	3 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Ketones, 1+	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Protein, trace	4 Participants	4 Participants	5 Participants	6 Participants	6 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Protein,1+	0 Participants	6 Participants	3 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Protein, 2+	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 2, Protein, 3+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Glucose, trace or 1/10 g/dL	5 Participants	4 Participants	5 Participants	11 Participants	6 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Glucose, 1+ or 1/4 g/dL	2 Participants	3 Participants	7 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Glucose, 2+ or 1/2 g/dL	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Glucose, 3+ or 1 g/dL	4 Participants	8 Participants	7 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Ketones, trace	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Protein, trace	2 Participants	7 Participants	5 Participants	5 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Protein, 1+	3 Participants	2 Participants	4 Participants	3 Participants	5 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Protein, 2+	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 3, Protein, 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Glucose, trace or 1/10 g/dL	4 Participants	3 Participants	8 Participants	5 Participants	7 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Glucose, 1+ or 1/4 g/dL	2 Participants	2 Participants	5 Participants	0 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Glucose, 2+ or 1/2 g/dL	4 Participants	1 Participants	5 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Glucose, 3+ or 1 g/dL	0 Participants	8 Participants	3 Participants	5 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Ketones, trace	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 4, Ketones, 1+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Glucose, 3+ or 1 g/dL	4 Participants	6 Participants	5 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Ketones, trace	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Protein, trace	3 Participants	2 Participants	1 Participants	4 Participants	1 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Protein, 1+	3 Participants	2 Participants	3 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Protein, 2+	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 16, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Glucose, trace or 1/10 g/dL	4 Participants	2 Participants	4 Participants	4 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Glucose, 1+ or 1/4 g/dL	4 Participants	2 Participants	1 Participants	3 Participants	3 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Glucose, 2+ or 1/2 g/dL	1 Participants	4 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Glucose, 3+ or 1 g/dL	4 Participants	3 Participants	4 Participants	4 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Ketones, trace	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Ketones, 1+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Protein, trace	3 Participants	8 Participants	4 Participants	2 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Protein, 1+	1 Participants	1 Participants	3 Participants	2 Participants	5 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Protein, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 20, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Glucose, trace or 1/10 g/dL	4 Participants	2 Participants	3 Participants	8 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Glucose, 1+ or 1/4 g/dL	1 Participants	1 Participants	5 Participants	2 Participants	7 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Glucose, 2+ or 1/2 g/dL	3 Participants	0 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Glucose, 3+ or 1 g/dL	1 Participants	7 Participants	1 Participants	3 Participants	5 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Ketones, trace	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Ketones, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Protein, trace	5 Participants	6 Participants	7 Participants	6 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Protein, 1+	0 Participants	1 Participants	3 Participants	2 Participants	5 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Protein, 2+	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 24, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Glucose, trace or 1/10 g/dL	6 Participants	7 Participants	3 Participants	9 Participants	4 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Glucose, 1+ or 1/4 g/dL	3 Participants	1 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Glucose, 2+ or 1/2 g/dL	0 Participants	3 Participants	0 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Glucose, 3+ or 1 g/dL	3 Participants	4 Participants	2 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Ketones, trace	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Ketones, 1+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Protein, trace	3 Participants	6 Participants	4 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Protein, 1+	0 Participants	2 Participants	4 Participants	1 Participants	5 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Protein, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Dipstick Result Week 25, Protein, 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Follow-up (Week 25)

Population: Safety Population.

The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).

Outcome measures

Outcome measures
Measure	DEN 45 mg n=61 Participants Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.	Placebo n=64 Participants Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 Participants Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 Participants Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 Participants Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 Participants Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 0-1	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 1-3	1 Participants	2 Participants	5 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 15-25	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 25-50	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 50-100	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 0-1	1 Participants	2 Participants	3 Participants	4 Participants	3 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 1-3	4 Participants	6 Participants	2 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 3-5	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 5-10	0 Participants	2 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 15-25	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 25-50	3 Participants	3 Participants	5 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, 50-100	0 Participants	4 Participants	0 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, WBC, innumerable	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 3-5	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 5-10	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 15-25	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 25-50	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 0-1	0 Participants	4 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 1-3	2 Participants	0 Participants	4 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 3-5	1 Participants	3 Participants	2 Participants	2 Participants	1 Participants	6 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 5-10	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 15-25	2 Participants	1 Participants	3 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 25-50	3 Participants	2 Participants	1 Participants	3 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, 50-100	0 Participants	3 Participants	0 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 13, WBC, innumerable	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 0-1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 1-3	1 Participants	5 Participants	5 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 3-5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 5-10	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 15-25	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 25-50	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, 50-100	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 3-5	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 0-1	3 Participants	3 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 1-3	1 Participants	0 Participants	1 Participants	3 Participants	5 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 3-5	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 5-10	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 15-25	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 25-50	3 Participants	4 Participants	3 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, 50-100	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 14, WBC, innumerable	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 0-1	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 1-3	1 Participants	2 Participants	4 Participants	1 Participants	0 Participants	5 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 3-5	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 5-10	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 15-25	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 25-50	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, RBC, innumerable	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 0-1	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 1-3	0 Participants	5 Participants	3 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 3-5	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 5-10	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 15-25	4 Participants	3 Participants	1 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 25-50	3 Participants	1 Participants	0 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, 50-100	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 15, WBC, innumerable	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 0-1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 1-3	1 Participants	4 Participants	5 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 3-5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 5-10	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 15-25	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 25-50	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, RBC, innumerable	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 0-1	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 1-3	3 Participants	1 Participants	2 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 3-5	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 5-10	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 15-25	3 Participants	1 Participants	2 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 25-50	2 Participants	5 Participants	5 Participants	3 Participants	5 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, 50-100	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 16, WBC, innumerable	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 0-1	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 1-3	2 Participants	2 Participants	5 Participants	4 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 3-5	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 5-10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 15-25	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 25-50	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, 50-100	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, RBC, innumerable	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 0-1	1 Participants	4 Participants	0 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 1-3	3 Participants	2 Participants	1 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 5-10	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 15-25	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 25-50	1 Participants	2 Participants	3 Participants	1 Participants	5 Participants	6 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, 50-100	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 20, WBC, innumerable	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 0-1	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 15-25	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 1-3	2 Participants	4 Participants	6 Participants	1 Participants	0 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 3-5	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 5-10	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 15-25	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 25-50	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, 50-100	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 0-1	2 Participants	5 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 1-3	1 Participants	2 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 3-5	3 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 5-10	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 15-25	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 25-50	2 Participants	2 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, 50-100	1 Participants	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 24, WBC, innumerable	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 0-1	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 1-3	3 Participants	2 Participants	1 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 3-5	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 5-10	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 25-50	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, RBC, innumerable	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 0-1	1 Participants	1 Participants	3 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 1-3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	6 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 3-5	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 5-10	2 Participants	0 Participants	3 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 15-25	1 Participants	4 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 25-50	3 Participants	1 Participants	3 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, 50-100	0 Participants	3 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 25, WBC, innumerable	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 0-1	2 Participants	3 Participants	1 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 1-3	1 Participants	3 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 3-5	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 5-10	1 Participants	2 Participants	3 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 15-25	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, ,25-50	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, 50-100	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, RBC, innumerable	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 0-1	1 Participants	7 Participants	4 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 1-3	2 Participants	2 Participants	1 Participants	4 Participants	3 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 3-5	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 5-10	2 Participants	3 Participants	3 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 15-25	1 Participants	4 Participants	2 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 25-50	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, 50-100	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week -5, WBC, innumerable	1 Participants	4 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 0-1	0 Participants	3 Participants	0 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 1-3	2 Participants	1 Participants	3 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 3-5	1 Participants	3 Participants	4 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 5-10	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 15-25	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 25-50	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, 50-100	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, RBC, innumerable	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 0-1	2 Participants	6 Participants	2 Participants	4 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 1-3	1 Participants	3 Participants	4 Participants	3 Participants	6 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 3-5	0 Participants	4 Participants	4 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 5-10	3 Participants	5 Participants	4 Participants	0 Participants	4 Participants	7 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 15-25	3 Participants	2 Participants	2 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 25-50	1 Participants	0 Participants	4 Participants	5 Participants	2 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, 50-100	1 Participants	0 Participants	2 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 0, WBC, innumerable	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 0-1	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 1-3	1 Participants	2 Participants	6 Participants	5 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 3-5	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 5-10	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 15-25	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 25-50	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, 50-100	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 0-1	4 Participants	3 Participants	1 Participants	3 Participants	3 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 1-3	0 Participants	6 Participants	6 Participants	6 Participants	5 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 3-5	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants	5 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 5-10	1 Participants	4 Participants	2 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 15-25	2 Participants	3 Participants	0 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 25-50	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, 50-100	2 Participants	3 Participants	1 Participants	4 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 1, WBC, innumerable	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 0-1	3 Participants	3 Participants	0 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 1-3	2 Participants	3 Participants	3 Participants	0 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 3-5	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 5-10	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 15-25	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 25-50	0 Participants	3 Participants	1 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, 50-100	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 0-1	6 Participants	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 1-3	0 Participants	6 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 3-5	3 Participants	1 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 5-10	2 Participants	4 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 15-25	1 Participants	2 Participants	0 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 25-50	2 Participants	3 Participants	3 Participants	4 Participants	2 Participants	9 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, 50-100	2 Participants	3 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 2, WBC, innumerable	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 0-1	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 1-3	0 Participants	1 Participants	4 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 3-5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 5-10	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 15-25	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 25-50	0 Participants	4 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, 50-100	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 0-1	4 Participants	1 Participants	2 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 1-3	3 Participants	4 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 3-5	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 5-10	2 Participants	4 Participants	4 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 15-25	1 Participants	2 Participants	3 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 25-50	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, 50-100	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	8 Participants
Number of Participants With Urinalysis Microscopic Result Week 3, WBC, innumerable	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 0-1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 1-3	4 Participants	3 Participants	3 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 3-5	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 5-10	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 15-25	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 25-50	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, 50-100	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, RBC, innumerable	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 0-1	2 Participants	5 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 1-3	1 Participants	5 Participants	2 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 3-5	1 Participants	1 Participants	5 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 5-10	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 10-15	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 15-25	2 Participants	0 Participants	3 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 25-50	1 Participants	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, 50-100	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 4, WBC, innumerable	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 0-1	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 1-3	2 Participants	1 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 3-5	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 5-10	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 15-25	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 25-50	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 0-1	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 1-3	1 Participants	4 Participants	5 Participants	6 Participants	4 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 3-5	2 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 5-10	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 10-15	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 15-25	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 25-50	4 Participants	5 Participants	3 Participants	4 Participants	3 Participants	6 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, 50-100	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 6, WBC, innumerable	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 0-1	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 1-3	1 Participants	1 Participants	5 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 3-5	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 5-10	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 10-15	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 15-25	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 25-50	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, 50-100	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, RBC, innumerable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 0-1	2 Participants	5 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 1-3	3 Participants	5 Participants	0 Participants	1 Participants	4 Participants	6 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 3-5	0 Participants	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 5-10	0 Participants	3 Participants	3 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 10-15	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 15-25	1 Participants	0 Participants	2 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 25-50	1 Participants	1 Participants	0 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, 50-100	1 Participants	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 8, WBC, innumerable	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 0-1	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 1-3	1 Participants	1 Participants	2 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 3-5	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Urinalysis Microscopic Result Week 12, RBC, 5-10	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Population: Sparse PK (PPK) Population comprised of all those participants who were assigned to the sparse (population PK) group. All consenting participants were eligible for inclusion in the sparse PK population except for those participants participating in the serial PK assessment. The data for this outcome measure was not collected.

A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Population: PPK Population. The data for this outcome measure was not collected.

A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

DEN 2.5 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

DEN 7.5 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

DEN 15 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

DEN 30 mg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

DEN 45 mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=64 participants at risk Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 participants at risk Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 participants at risk Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 participants at risk Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 participants at risk Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.	DEN 45 mg n=61 participants at risk Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Infections and infestations Gastroenteritis	1.6% 1/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Infections and infestations Laryngitis	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Infections and infestations Sepsis	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Nervous system disorders Cerebrovascular accident	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Nervous system disorders Hemiparesis	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Nervous system disorders Ischaemic stroke	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Cardiac disorders Acute myocardial infarction	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Cardiac disorders Cardiac failure congestive	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Ear and labyrinth disorders Vertigo	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Gastrointestinal disorders Diverticular perforation	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Metabolism and nutrition disorders Dehydration	0.00% 0/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.

Other adverse events

Other adverse events
Measure	Placebo n=64 participants at risk Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.	DEN 2.5 mg n=61 participants at risk Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.	DEN 7.5 mg n=63 participants at risk Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.	DEN 15 mg n=66 participants at risk Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.	DEN 30 mg n=60 participants at risk Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.	DEN 45 mg n=61 participants at risk Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Infections and infestations Nasopharyngitis	4.7% 3/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	4.9% 3/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	11.1% 7/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	4.5% 3/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	5.0% 3/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Gastrointestinal disorders Nausea	1.6% 1/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	3.3% 2/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	3.2% 2/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	6.1% 4/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.7% 1/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Gastrointestinal disorders Diarrhoea	1.6% 1/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.5% 1/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	5.0% 3/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	1.6% 1/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.
Musculoskeletal and connective tissue disorders Back pain	1.6% 1/64 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/63 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	6.1% 4/66 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	0.00% 0/60 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.	3.3% 2/61 • AE's were collected up to Follow-up (up to Week 25) Safety Population was used.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER