Sotagliflozin vs. Placebo added to insulin +/- other OADs in T2DM
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
IRAS ID
229939
Contact name
Manish Saxena
Contact email
Sponsor organisation
Sanofi-aventis Recherche & Développement
Eudract number
2016-001804-43
Duration of Study in the UK
1 years, 5 months, 10 days
Research summary
Diabetes is among the leading causes of death by disease and is a leading cause of heart disease, stroke, blindness, kidney disease, and amputation Despite the fact that the population of people with diabetes is growing, none of the current therapies are curative and the results of treatment are variable.
Although lifestyle changes, including diet, exercise, and education, are valuable components of diabetes treatment, the vast majority of people with T2D must receive treatment to control the disease.
The purpose of this study is to determine whether sotagliflozin (SGLT1 and SLGT2 inhibitors) taken by mouth once daily lowers haemoglobin A1C (glycated haemoglobin, a blood test that measures how well a patient’s blood sugar is controlled over time) better than placebo (a tablet which looks like sotagliflozin but has no active drug in it) for the treatment of T2DM in patients who are already taking insulin. Patients who are found to be eligible for the study will be consented and they will follow a screening phase (up to 2 weeks), a 4-week run-in phase, a 52-week main treatment period and a 2-week post-treatment follow-up period.
Patients will be randomly assigned in a 2:1:1 ratio to receive either:
- Sotagliflozin 400 mg, given as 2 sotagliflozin 200 mg tablets, once daily before the first meal of the day.
- Sotagliflozin 200 mg, given as 2 tablets: 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), once daily before the first meal of the day.
- Placebo, given as 2 placebo tablets (identical to sotagliflozin 200 mg in appearance), once daily before the first meal of the day.This is a multicenter, randomised, double blind, and parallel group study.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1451
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion