Trial Outcomes & Findings for A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control (NCT NCT03242018)

NCT ID: NCT03242018

Last Updated: 2021-06-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

277 participants

Primary outcome timeframe

Baseline to Week 26

Results posted on

2021-06-25

Participant Flow

Participants took part in the study at 106 investigative sites in United States, Argentina, Brazil, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine from 16 August 2017 to 11 December 2019.

A total of 277 participants with a diagnosis of Type 2 Diabetes Mellitus were randomized 1:1:1 to 1 of the 3 treatment groups: Placebo, Sotagliflozin 200 milligram (mg) and Sotagliflozin 400 mg.

Participant milestones

Participant milestones
Measure	Placebo Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 200 mg Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.	Sotagliflozin 400 mg Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Overall Study STARTED	93	92	92
Overall Study COMPLETED	75	78	78
Overall Study NOT COMPLETED	18	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 200 mg Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.	Sotagliflozin 400 mg Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Overall Study Adverse Event	7	7	6
Overall Study Lost to Follow-up	2	2	2
Overall Study At the Participant's Own Request	5	1	4
Overall Study Reason Not Specified	3	4	1
Overall Study Study Terminated by Sponsor	1	0	1

Baseline Characteristics

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 200 mg n=92 Participants Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Total n=277 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 8.3 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	67.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	67.4 years STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	48 Participants n=7 Participants	43 Participants n=5 Participants	142 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	44 Participants n=7 Participants	49 Participants n=5 Participants	135 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	107 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	59 Participants n=7 Participants	59 Participants n=5 Participants	170 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants	73 Participants n=7 Participants	78 Participants n=5 Participants	227 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Argentina	7 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Brazil	9 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants
Region of Enrollment Colombia	5 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment Germany	2 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Hungary	1 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Israel	7 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants	17 participants n=4 Participants
Region of Enrollment Italy	5 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment Mexico	10 participants n=5 Participants	11 participants n=7 Participants	11 participants n=5 Participants	32 participants n=4 Participants
Region of Enrollment Poland	7 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants	21 participants n=4 Participants
Region of Enrollment Romania	2 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Russia	10 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	26 participants n=4 Participants
Region of Enrollment South Africa	3 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Spain	7 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants	28 participants n=4 Participants
Region of Enrollment Ukraine	2 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	14 participants n=5 Participants	48 participants n=4 Participants
Hemoglobin A1c (HbA1c)	8.38 percentage of HbA1c STANDARD_DEVIATION 1.06 • n=5 Participants	8.28 percentage of HbA1c STANDARD_DEVIATION 1.03 • n=7 Participants	8.25 percentage of HbA1c STANDARD_DEVIATION 0.87 • n=5 Participants	8.30 percentage of HbA1c STANDARD_DEVIATION 0.99 • n=4 Participants
Systolic Blood Pressure (SBP)	144.72 millimeter of mercury (mmHg) STANDARD_DEVIATION 15.56 • n=5 Participants	143.10 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.98 • n=7 Participants	144.20 millimeter of mercury (mmHg) STANDARD_DEVIATION 15.10 • n=5 Participants	144.01 millimeter of mercury (mmHg) STANDARD_DEVIATION 15.17 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 26

Population: Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.

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

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo	-0.11 percentage of HbA1c Standard Error 0.151	-0.40 percentage of HbA1c Standard Error 0.131	—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo	-0.11 percentage of HbA1c Standard Error 0.151	-0.07 percentage of HbA1c Standard Error 0.162	—

SECONDARY outcome

Timeframe: Baseline to Week 26

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	0.069 millimole per liter (mmol/L) Standard Error 0.4482	-0.291 millimole per liter (mmol/L) Standard Error 0.5056	-0.644 millimole per liter (mmol/L) Standard Error 0.4348

SECONDARY outcome

Timeframe: Baseline to Week 26

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in Body Weight at Week 26	0.39 kilogram (kg) Standard Error 0.615	-0.43 kilogram (kg) Standard Error 0.480	-1.02 kilogram (kg) Standard Error 0.490

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Analysis population included all 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 control-based copy reference multiple imputation under the missing not at random framework.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=68 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=73 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg	-2.70 mmHg Standard Error 1.815	-4.84 mmHg Standard Error 1.882	-7.10 mmHg Standard Error 1.842

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Change From Baseline in SBP at Week 12 for All Participants	-2.50 mmHg Standard Error 1.762	-5.74 mmHg Standard Error 1.752	-7.86 mmHg Standard Error 1.794

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Analysis population included all participants with baseline UACR \> 30 mg/g in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.

An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=71 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=75 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)	-4.56 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.	-26.99 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.	-30.66 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

SECONDARY outcome

Timeframe: Week 26

Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Percentage of Participants With HbA1c <6.5% at Week 26	2.2 percentage of participants	5.4 percentage of participants	8.7 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=92 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Percentage of Participants With HbA1c <7.0% at Week 26	4.3 percentage of participants	16.3 percentage of participants	17.4 percentage of participants

SECONDARY outcome

Timeframe: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks

Population: Safety population included all randomized participants who received at least one dose of double-blind IMP. Two participants were randomized to Sotagliflozin 400 mg and dosed with Sotagliflozin 200 mg and 400 mg treatments during the study. Data for these participants were summarized in the Sotagliflozin 200 mg arm in the safety population.

An adverse event (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 the investigational medicinal product (IMP).

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=94 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=90 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	82.8 percentage of participants	86.2 percentage of participants	81.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 56.3 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).

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=93 Participants Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 400 mg n=94 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.	Sotagliflozin 400 mg n=90 Participants Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Percentage of Participants With Hypoglycemic Events Any hypoglycemia	40.9 percentage of participants	40.4 percentage of participants	38.9 percentage of participants
Percentage of Participants With Hypoglycemic Events Documented symptomatic hypoglycemia	35.5 percentage of participants	28.7 percentage of participants	27.8 percentage of participants
Percentage of Participants With Hypoglycemic Events Severe or documented symptomatic hypoglycemia	35.5 percentage of participants	30.9 percentage of participants	27.8 percentage of participants

Adverse Events

Placebo

Serious events: 21 serious events

Other events: 44 other events

Deaths: 6 deaths

Sotagliflozin 200 mg

Serious events: 18 serious events

Other events: 44 other events

Deaths: 6 deaths

Sotagliflozin 400 mg

Serious events: 20 serious events

Other events: 29 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=93 participants at risk Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.	Sotagliflozin 200 mg n=94 participants at risk Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.	Sotagliflozin 400 mg n=90 participants at risk Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Vascular disorders Hypertension	5.4% 5/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	1.1% 1/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.3% 3/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Investigations Glomerular filtration rate decreased	3.2% 3/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	10.6% 10/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	8.9% 8/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Gastrointestinal disorders Diarrhoea	3.2% 3/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.3% 5/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.6% 5/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Renal and urinary disorders Renal impairment	7.5% 7/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.3% 5/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.3% 3/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 5/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.2% 3/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	2.2% 2/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Metabolism and nutrition disorders Hyperkalaemia	2.2% 2/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	9.6% 9/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.6% 5/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Metabolism and nutrition disorders Hyperuricaemia	6.5% 6/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	2.1% 2/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	1.1% 1/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Metabolism and nutrition disorders Vitamin D deficiency	6.5% 6/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	9.6% 9/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	3.3% 3/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Influenza	5.4% 5/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.3% 5/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	2.2% 2/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Nasopharyngitis	4.3% 4/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	8.5% 8/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	1.1% 1/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Urinary tract infection	17.2% 16/93 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	10.6% 10/94 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	6.7% 6/90 • Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.

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