Phase 3
Completed N=571
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
Source: ClinicalTrials.gov NCT03285594 ↗Enrolled (actual)
571
Serious AEs
11.1%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 — -0.27; -0.72; -0.81 percentage of HbA1c — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Primary Objective:
To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).
Secondary Objectives:
* To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
* To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
* To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 |
-0.27; -0.72; -0.81 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 |
12.882; -2.975; -8.949 | 0.0006 sig |
| SECONDARY Change From Baseline in Body Weight at Week 18 |
0.36; -0.73; -1.37 | 0.0007 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12 |
-4.67; -8.58; -8.50 | 0.04 sig |
| SECONDARY Change From Baseline in SBP at Week 12 for All Participants |
-0.21; -5.15; -4.10 | 0.0018 sig |
| SECONDARY Change From Baseline in HbA1c at Week 52 |
0.00; -0.52; -0.57 | 0.1265 |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
-0.18; -1.19; -0.83 | 0.2466 |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
64.6; 54.6; 59.3 | — |
Eligibility Criteria
Inclusion criteria
- Participants with Type 2 Diabetes Mellitus (T2DM) using any types of basal insulin alone or in combination with up to 2 OADs.
- Participants have given written informed consent to participate in the study in accordance with local regulations.
Exclusion criteria
- At the time of Screening age 10.5% measured by the central laboratory at Screening.
- HbA1c 180 mmHg (systolic blood pressure [SBP]) or >100 mmHg (diastolic blood pressure [DBP]).
- History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range
- Total bilirubin >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03285594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.