NCT02926937

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

Completed Phase 3 Results posted Last updated 21 June 2021

What this trial tests

Phase 3 trial testing Sotagliflozin (SAR439954) in Type 2 Diabetes Mellitus in 399 participants. Completed in 17 May 2019.

Timeline

11 November 2016

Primary endpoint
22 April 2019

17 May 2019

Quick facts

Lead sponsor	Lexicon Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	399
Start date	11 November 2016
Primary completion	22 April 2019
Estimated completion	17 May 2019
Sites	70 locations across Canada, United States, Mexico

Drugs / interventions tested

• Sotagliflozin (SAR439954) — full drug profile →
• Placebo

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Lexicon Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) Primary · Baseline to Week 26

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

Group	Value	95% CI
Placebo	-0.34	± 0.120
Sotagliflozin 400 mg	-1.03	± 0.122

Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.591	± 0.1943
Sotagliflozin 400 mg	-1.156	± 0.1964

Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.500	± 0.2443
Sotagliflozin 200 mg	-0.847	± 0.2477

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.201	± 0.2739
Sotagliflozin 400 mg	-1.756	± 0.2719

Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) Secondary · Baseline to Week 12

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-4.45	± 2.419
Sotagliflozin 400 mg	-7.96	± 2.282

Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) Secondary · Baseline to Week 12

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.57	± 1.088
Sotagliflozin 400 mg	-1.35	± 1.116

Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) Secondary · Baseline to Week 12

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-1.62	± 1.215
Sotagliflozin 200 mg	-4.82	± 1.211

Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.79	± 0.373
Sotagliflozin 400 mg	-2.33	± 0.379

Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.52	± 0.509
Sotagliflozin 200 mg	-1.69	± 0.518

Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) Secondary · Week 26

Group	Value	95% CI
Placebo	10.7
Sotagliflozin 400 mg	23.2

Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) Secondary · Week 26

Group	Value	95% CI
Placebo	28.0
Sotagliflozin 400 mg	47.2

Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) Secondary · Baseline to Week 26

An ANCOVA model was used for the analysis.

Group	Value	95% CI
Placebo	-0.26	± 0.143
Sotagliflozin 200 mg	-0.93	± 0.148

Adverse events — posted to ClinicalTrials.gov

Time frame: First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 3/150 (2%)

Deaths: 0/150

Sotagliflozin 400 mg

Serious: 3/142 (2%)

Deaths: 0/142

Sotagliflozin 200 mg

Serious: 2/107 (2%)

Deaths: 0/107

Serious adverse events (12 terms)

Reaction	System	Placebo	Sotagliflozin 400 mg	Sotagliflozin 200 mg
Retinal detachment	Eye disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Multiple fractures	Injury, poisoning and procedural complications	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—
Traumatic haemothorax	Injury, poisoning and procedural complications	—	—	—
Traumatic lung injury	Injury, poisoning and procedural complications	—	—	—
Depression	Psychiatric disorders	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—
Chronic kidney disease	Renal and urinary disorders	—	—	—
Peripheral artery thrombosis	Vascular disorders	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	Sotagliflozin 400 mg	Sotagliflozin 200 mg
Diarrhoea	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—

Most-reported serious reactions: Retinal detachment, Colitis, Gastrooesophageal reflux disease, Lower gastrointestinal haemorrhage, Multiple fractures, Road traffic accident, Traumatic haemothorax, Traumatic lung injury.

Data from ClinicalTrials.gov NCT02926937 adverse events section.

Sponsor's own description

Primary Objective:

To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.

Secondary Objectives:

* To compare Sotagliflozin 400 mg versus placebo based on:
* Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
* Change from baseline in fasting plasma glucose (FPG).
* Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter per mercury (mmHg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Proportion of participants with HbA1c \<6.5%, \<7.0%.
* To compare Sotagliflozin 200 mg versus placebo based on:
* Change from baseline in HbA1c.
* Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
* Change from baseline in body weight.
* Change from baseline in SBP for all participants.
* To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.