Efficacy and safety of LX4211 added to insulin in Type 1 Diabetes
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy.
IRAS ID
174853
Contact name
Shenaz Ramtoola
Contact email
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2014-005153-39
Duration of Study in the UK
1 years, 8 months, 5 days
Research summary
Patients with Type 1 Diabetes Mellitus who have inadequate control of their blood glucose with insulin treatment alone are being asked to consider taking part in a clinical research study to test an oral study drug that is added to the insulin treatment. The purpose of this study is to find out if the study drug (LX4211) lowers haemoglobin A1C (a marker of blood glucose over time) better than placebo (a tablet that looks like LX4211 but has no active drug in it) for the treatment of Type 1 Diabetes Mellitus. The study will also test for possible changes in fasting glucose, body weight, blood pressure, insulin dose requirements, hypoglycaemic events, kidney function and patients’ general sense of well-being, and evaluate the safety and tolerability of the tablet compared to placebo.
The study will consist of three treatment groups: i) LX4211 high dose once daily, ii) LX4211 medium dose once daily, iii) placebo once daily. Approximately 750 people from various European countries are expected to participate in this study. Patients must be at least 18 years of age with a known diagnosis of Type 1 Diabetes Mellitus and inadequate control of their blood glucose with insulin therapy alone. Patients should be taking insulin via multiple daily injections or an insulin pump (CSII- continuous subcutaneous insulin infusion). Patients will need to go through some additional medical checks to confirm they are eligible to participate in the study. Patients meeting the required criteria to participate in the study will enter a 6-week period of the study to optimise their insulin doses. During this period, they will have to check their glucose levels 5 times/ day on at least 5 days/ week and have weekly telephone calls with the study staff to make any necessary adjustments to their insulin dose. After this period, they will be assigned (with equal chance of being assigned to take one of three tablets: high dose study drug, medium dose study drug or placebo. They will continue taking the study tablet daily for 52 weeks. After 4 weeks of the last dose, 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, completion of questionnaires, completion of diaries and finger stick glucose measurements. The study is sponsored by Lexicon Pharmaceuticals, Inc.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0319
Date of REC Opinion
14 May 2015
REC opinion
Further Information Favourable Opinion