MB102 230 Phase III study of Dapagliflozin in Type1 Diabetes Mellitus
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus - Study Two
IRAS ID
183747
Contact name
Stephen Bain
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-004599-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 24 days
Research summary
Type 1 diabetes is a chronic disorder caused by the bodies inability to produce insulin. A lack of insulin causes an increase in blood and urine glucose levels. Type 1 diabetes can be treated with life-long insulin injections.
Despite treatment with insulin, some patients still have an increased blood sugar level.
Dapagliflozin is a medicine being developed for use in addition to insulin therapy. Dapagliflozin is currently approved for use as treatment in patients with Type 2 Diabetes Mellitus who are injecting insulin.The study is a 68 week, Multicenter, Randomised, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus.
Approximately 768 patients will be randomised in this trial. There will be approximately 41 patients randomised in the UK. Eligible patients will start on an eight week lead-in period, to optimise their diabetes management and to assess their blood glucose levels at a base-line and in order to record any hypoglycaemic episodes.
Throughout the study, participants will undergo physical examinations, vital signs and ECG. Blood and urine will be taken for various tests and diet and exercise counselling will be given.
The addition of this new treatment will hopefully be better than the current treatment for Type 1 Diabetes (life-long insulin therapy). Insulin therapy is associated with weight gain and insulin resistance and this may also impact the patients risk of cardiovascular disease. In addition, a large proportion of patients are unable to achieve recommended glycemic levels with insulin alone because of the challenges associated with insulin therapy.
Dapagliflozin will be used as an add on to insulin therapy to improve glycaemic control. Secondary benefits include reductions in insulin dose, hypoglycaemia and glycaemic variability and reducing the risk of weight gain.
REC name
Wales REC 3
REC reference
15/WA/0241
Date of REC Opinion
28 Aug 2015
REC opinion
Further Information Favourable Opinion