SOTA-EMPA
Research type
Research Study
Full title
A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
IRAS ID
233236
Contact name
Simon Heller
Contact email
Sponsor organisation
SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Eudract number
2016-001803-22
Duration of Study in the UK
1 years, 7 months, days
Research summary
According to the World Health Organization, there are about 60 million people with diabetes in
The European Region, or about 10.3% of men and 9.6% of women aged 25 years and over.
While these numbers include both people with T2D and type 1 diabetes (T1D), over 90% of
adults with diabetes have 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.
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 Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl
Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin.
This study is a Phase 3, multicenter and multinational, 2:2:1 randomized, double-blind (single-blind Run-in Phase), placebo and active-controlled, parallel-group study that is anticipated to enrol approximately 700 subjects. Patients with T2D who have inadequate glycaemic control on dipeptidyl peptidase 4 inhibitor (DPP4[i]) with or without metformin for at least 12 weeks prior to Screening will be eligible for enrolment in this study. To ensure an approximately equal number of patients have Screening SBP <130 mmHg or SBP ≥130 mmHg, the number of patients enrolled in each category will be limited to 60% of all patients (≤420 patients).a Screening Phase up to 2-weeks and a 2-week, single-blind Run-in phase prior to randomization, followed by a 26-week Double-blind Treatment Phase and a 4-week post-treatment Follow-up visit. To
qualify for randomization, patients must demonstrate compliance based upon tablet count (≥80%) during the Run-in Phase. Randomization will be stratified by:• HbA1c at Screening (≤8.5%, >8.5%)
• SBP at Screening (<130 mmHg, ≥130 mmHg)
• Metformin use at Screening (Yes, No).Patients will be randomly assigned 2:2:1 to the following 3 treatment groups on top of DPP4(i) with or without metformin:
• Sotagliflozin 400 mg
• Empagliflozin 25 mg
• Placebo.Sotagliflozin, Empagliflozin and Placebo will be administered as 2 tablets once daily and will look identical to prevent unblinding.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0390
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion