Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Product Name: Dapagliflozin
Product Code: BMS-512148
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dapagliflozin
Current
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of a written informed consent Diagnosed with type 2 diabetes Men or women equal or above 18 years WOCBP must be using an adequate method of contraception Treated with OAD therapy that includes metformin for at least 8 weeks prior to enrolment HbA1c above 6.5% and equal or below 10.0% FPG equal or below 270 mg/dL C-peptid level equal or above 1.0 ng/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Type 1 diabetes, history of ketoacidosis or hyperosmolar non-ketonic coma, or corticosteroid-induced type 2 diabetes Symptoms of poorly controlled diabetes History of unstable or rapidly progressing renal disease Known condition of congenital renal glucosuria History of severe hepatobiliary disease or hepatotoxicity with any medication Pregnant or breasefeeding patients Insulin therapy within 1 year of enrolment Treatement with glucocorticoids within the last 30 days Congestive heart failure defined as NYHA class III or IV Significant cardiovascular history within the past 6 months Renal failure or renal dysfunction (Creatinine-clearance less than 60 ml/min) Urine albumin:creatinine ratio above 1,800 mg/g Severe hepatic insufficiency and/or significant abnormal liver function Serum total bilirubin above 2 mg/dL Creatinine kinase above 3 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether, after 52 weeks of oral administration of double-blind treatment, the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide (sulphonylurea) plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. Objectives after the 52-week extension period: - To assess the same safety and tolerability parameters as for the first 52 weeks, over 104 weeks treatment - To assess the maintenance of efficacy of dapagliflozin plus metformin over 104 weeks of treatment ; Secondary Objective: - To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin after 52 weeks of treatment - To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin after 52 weeks of treatment - To show that a higher percentage of patients treated with dapagliflozin plus metformin reduce their baseline body weight with at least 5% compared to patients treated with glipizide plus metformin after 52 weeks of treatment. ; Primary end point(s): Primary outcome variable - Change in HbA1c from baseline to week 52 Key secondary outcome variables - Absolute change in body weight from baseline to week 52 - Proportion of patients reporting at least one episode of hypoglycaemia over 52 weeks - Proportion of patients with body weight decrease = 5% from baseline to week 52 | — |
Countries
France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed