Evaluation of Net Clinical Benefit of Sotagliflozin added to Insulin
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
IRAS ID
184626
Contact name
Shenaz Ramtoola
Contact email
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2015-001709-15
Duration of Study in the UK
1 years, 4 months, 7 days
Research summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused when the body’s immune system attacks and damages cells in the body that produce insulin. When the body cannot produce enough of its own insulin, sugar levels in the blood can rise. A person with T1DM needs insulin treatment to control their blood sugar levels. The purpose of this study is to test the safety of sotagliflozin and check how well it works in controlling blood sugar levels when it is added to the patients background insulin regimen. The study is sponsored by Lexicon Pharmaceuticals, Inc. Sotagliflozin is a medicine which is not yet approved for doctors to treat patients with T1DM. We want to find out what effects sotagliflozin will have on people with T1DM, including changes in blood sugar control, changes in the amount of insulin required, changes in body weight and blood pressure. The study will also test if adding sotagliflozin may decrease the risk of low blood sugar and diabetic ketoacidosis, both of which are known complications in patients type 1 diabetes. At the start of the study patients will be randomly (by chance) allocated to one of 2 study groups (sotagliflozin 400 mg daily or placebo). Approximately 1400 patients from various countries across the world will participate in this study. Patients must be at least 18 years of age with a known diagnosis of Type 1 Diabetes Mellitus, and a body mass index (BMI) of greater than or equal to 18.5kg/m2. Patients will take 2 tablets of the study drug every morning before the first meal of the day for 24 weeks. There may be reasons why you are not allowed to take part in this study. The study doctor or staff will discuss these and any other reasons why you may not be allowed to enter the study. Four weeks after the last dose of study drug (sotagliflozin or placebo), patients will receive a phone call to check if they experienced any medical problems since their last clinic visit. Procedures for this study will include: physical examinations, blood and urine sample collection, finger stick blood glucose and ketone measurements, height, weight and vital sign measurements, electrocardiograms, completion of patient diaries. Participants will also have the opportunity to take part in an optional sub-study. The purpose of the sub-study is to evaluate the effect of the study medication on satiety (how full the patient feels after eating). Participants who decide to take part in the sub-study will be asked to complete a daily diary for 2 weeks at the beginning and the end of the study.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0626
Date of REC Opinion
9 Sep 2015
REC opinion
Further Information Favourable Opinion