Sotagliflozin vs. Placebo added to Sulfonylurea +/- Metformin in T2DM
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea alone or in combination with Metformin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or with Metformin
IRAS ID
221082
Contact name
Paul Walukiewicz
Contact email
Sponsor organisation
Sanofi-aventis Recherche & Développement
Eudract number
2016-002826-35
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Over 90% of adults diagnosed with diabetes have Type 2 Diabetes (T2D). 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. In the United States (US) and Europe, metformin is the standard first-line treatment
The purpose of this study is to evaluate how safe and effective Sotagliflozin is in the treatment of T2D when added to a Sulfonylurea alone or in combination with Metformin, in patients that have inadequate glycaemic control with these treatments alone. Patients who are found to be eligible for the study will be consented and they will follow a screening period (up to 2 weeks), a run in period (2 weeks), an initial core treatment period (26 weeks) with an extension period (53 weeks) then a FU period of 2 weeks.
Participants will be randomised to either receive Sotagliflozin or placebo tablets in a 1:1 ratio in a double blind manner. Randomisation will be stratified by:
• HbA1c at Screening (≤8.0%, >8.0%)
• Metformin use at Screening (Yes, No)
• SBP at Screening (<130 mmHg, ≥130 mmHg)
Both Sotagliflozin and the placebo will be administered as 2 tablets once daily and will look identical to prevent unblinding.
This is a multicentre, multinational, randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of Sotagliflozin added to a Sulfonylurea alone or in combination with Metformin in patients with T2D.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0130
Date of REC Opinion
6 Jun 2017
REC opinion
Further Information Favourable Opinion