Trial Outcomes & Findings for Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents (NCT NCT03285594)

NCT ID: NCT03285594

Last Updated: 2021-05-11

Results Overview

An analysis of covariance (ANCOVA) model was used for the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

571 participants

Primary outcome timeframe

Baseline and Week 18

Results posted on

2021-05-11

Participant Flow

Participants took part in the study at 101 investigative sites in the United States, Bulgaria, Canada, Czech Republic, France, Hungary, Slovakia, the United Kingdom from 15 September 2017 to 27 September 2019.

Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups, placebo, sotagliflozin 200 milligrams (mg) and sotagliflozin 400 mg. Participants were randomized at a ratio of 1:1:2 respectively to 1 of 3 groups.

Participant milestones

Participant milestones
Measure	Placebo Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs \[OADs\]) continued throughout the study.	Sotagliflozin 200 mg Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Overall Study STARTED	144	141	286
Overall Study Treated	144	141	285
Overall Study COMPLETED	129	130	249
Overall Study NOT COMPLETED	15	11	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs \[OADs\]) continued throughout the study.	Sotagliflozin 200 mg Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Overall Study At the Participant's Own Request	10	5	21
Overall Study Adverse Event	2	2	6
Overall Study Poor Compliance to Protocol	0	0	1
Overall Study Lost to Follow-up	0	0	1
Overall Study Reason Not Specified	3	4	8

Baseline Characteristics

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Total n=571 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 8.9 • n=5 Participants	62.1 years STANDARD_DEVIATION 10.2 • n=7 Participants	62.7 years STANDARD_DEVIATION 9.1 • n=5 Participants	62.4 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	65 Participants n=7 Participants	132 Participants n=5 Participants	255 Participants n=4 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	76 Participants n=7 Participants	154 Participants n=5 Participants	316 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	25 Participants n=7 Participants	42 Participants n=5 Participants	79 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=5 Participants	113 Participants n=7 Participants	239 Participants n=5 Participants	481 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) White	117 Participants n=5 Participants	124 Participants n=7 Participants	234 Participants n=5 Participants	475 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Bulgaria	9 participants n=5 Participants	13 participants n=7 Participants	35 participants n=5 Participants	57 participants n=4 Participants
Region of Enrollment Canada	7 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants	29 participants n=4 Participants
Region of Enrollment Czechia	14 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants	49 participants n=4 Participants
Region of Enrollment France	8 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants	30 participants n=4 Participants
Region of Enrollment Hungary	12 participants n=5 Participants	13 participants n=7 Participants	21 participants n=5 Participants	46 participants n=4 Participants
Region of Enrollment Slovakia	24 participants n=5 Participants	21 participants n=7 Participants	32 participants n=5 Participants	77 participants n=4 Participants
Region of Enrollment United Kingdom	0 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment United States	70 participants n=5 Participants	69 participants n=7 Participants	140 participants n=5 Participants	279 participants n=4 Participants
Hemoglobin A1c (HbA1c)	8.76 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=5 Participants	8.76 percentage of HbA1c STANDARD_DEVIATION 0.83 • n=7 Participants	8.69 percentage of HbA1c STANDARD_DEVIATION 0.80 • n=5 Participants	8.72 percentage of HbA1c STANDARD_DEVIATION 0.80 • n=4 Participants
Systolic Blood Pressure (SBP)	137.59 millimeter of Mercury (mmHg) STANDARD_DEVIATION 14.12 • n=5 Participants	136.40 millimeter of Mercury (mmHg) STANDARD_DEVIATION 15.54 • n=7 Participants	135.84 millimeter of Mercury (mmHg) STANDARD_DEVIATION 14.95 • n=5 Participants	136.42 millimeter of Mercury (mmHg) STANDARD_DEVIATION 14.89 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.

An analysis of covariance (ANCOVA) model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18	-0.27 percentage of HbA1c Standard Error 0.073	-0.72 percentage of HbA1c Standard Error 0.073	-0.81 percentage of HbA1c Standard Error 0.056

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.

FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	12.882 milligram per deciliter (mg/dL) Standard Error 3.6045	-2.975 milligram per deciliter (mg/dL) Standard Error 3.6083	-8.949 milligram per deciliter (mg/dL) Standard Error 2.7550

SECONDARY outcome

Timeframe: Baseline and Week 18

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in Body Weight at Week 18	0.36 kilogram (kg) Standard Error 0.249	-0.73 kilogram (kg) Standard Error 0.250	-1.37 kilogram (kg) Standard Error 0.190

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Analysis population included participants with baseline SBP ≥ 130 mmHg in ITT population where, ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.

An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=92 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=171 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12	-4.67 mmHg Standard Error 1.470	-8.58 mmHg Standard Error 1.447	-8.50 mmHg Standard Error 1.103

SECONDARY outcome

Timeframe: Baseline to Week 12

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in SBP at Week 12 for All Participants	-0.21 mmHg Standard Error 1.120	-5.15 mmHg Standard Error 1.117	-4.10 mmHg Standard Error 0.867

SECONDARY outcome

Timeframe: Baseline and Week 52

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in HbA1c at Week 52	0.00 percentage of HbA1c Standard Error 0.279	-0.52 percentage of HbA1c Standard Error 0.152	-0.57 percentage of HbA1c Standard Error 0.114

SECONDARY outcome

Timeframe: Baseline and Week 52

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=286 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Change From Baseline in Body Weight at Week 52	-0.18 kg Standard Error 0.579	-1.19 kg Standard Error 0.620	-0.83 kg Standard Error 0.374

SECONDARY outcome

Timeframe: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks

Population: Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).

An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=285 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Percentage of Participants With Adverse Events (AEs)	64.6 percentage of participants	54.6 percentage of participants	59.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 55.7 weeks

Population: Safety population included all randomised participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).

Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\].

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=285 Participants Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Percentage of Participants With Hypoglycemic Events Any hypoglycemia	62.5 percentage of participants	56.0 percentage of participants	62.8 percentage of participants
Percentage of Participants With Hypoglycemic Events Documented symptomatic hypoglycemia	44.4 percentage of participants	41.8 percentage of participants	46 percentage of participants
Percentage of Participants With Hypoglycemic Events Severe or documented symptomatic hypoglycemia	44.4 percentage of participants	41.8 percentage of participants	46 percentage of participants

Adverse Events

Placebo

Serious events: 16 serious events

Other events: 30 other events

Deaths: 2 deaths

Sotagliflozin 200 mg

Serious events: 19 serious events

Other events: 18 other events

Deaths: 1 deaths

Sotagliflozin 400 mg

Serious events: 28 serious events

Other events: 45 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=144 participants at risk Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 200 mg n=141 participants at risk Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.	Sotagliflozin 400 mg n=285 participants at risk Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Metabolism and nutrition disorders Vitamin D deficiency	6.2% 9/144 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	2.8% 4/141 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.5% 10/285 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Nasopharyngitis	4.9% 7/144 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	6.4% 9/141 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	4.9% 14/285 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Upper respiratory tract infection	5.6% 8/144 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	0.71% 1/141 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	4.9% 14/285 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Urinary tract infection	5.6% 8/144 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	4.3% 6/141 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.9% 11/285 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.

Additional Information

Medical Affairs

Lexicon Pharmaceuticals, Inc.

Phone: (510) 338-6064

Email: [email protected]

Results disclosure agreements

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