Type 2 Diabetes Mellitis MedDRA version: 12.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Product Name: Dapagliflozin
Product Code: BMS-512148
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BMS-512148
Other descriptive name: Dapagliflozin
Concentration unit: mg milligram(s)
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures 2. Diagnosis of T2DM 3. Men or women age = 18 to =77 years old at time of consenting 4. Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy =1500mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted. 5. HbA1c =6.7% and =10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1. Note 1: In the case that Stratum 1 has met its goal for randomised patients, communication will be sent out to all sites that screening and enrollment will only continue for patients in Stratum 2 with an HbA1c =7.2% and =10.5%. For these patients in Stratum 2, randomisation criteria of HbA1c =7.0% and =10.0% will apply (see also inclusion criterion no. 6, Note 2, below). 6. HbA1c =6.5% and =10.0%, based on central laboratory values obtained at Visit 3, one week prior to randomisation. Note 2: In the case that Stratum 1 has met its goal for randomised patients, HbA1c randomisation criteria will change to those applicable for Stratum 2: HbA1c =7.0% and =10.0%, based on central lab values at Visit 3, one week prior to randomisation. 7. Women of childbearing potential (WOCBP) who comply with the following: - Use a highly effective method of birth control (see below) to avoid pregnancy throughout the study and for up to 4 weeks after the study - Have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication and at each visit 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: 1.Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus 2. History of diabetic ketoacidosis 3. Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment 4. FPG >270 mg/dL (>15 mmol/L) 5. BMI > 45 kg/m2 6. History of bariatric surgery (ie, any surgery to treat obesity; for example, gastric banding or procedures that involve bypassing or transposing sections of the small intestine). History of liposuction is allowed. 7. Diabetes insipidus 8. Thyroid-stimulating hormone (TSH) and free T4 values outside normal range. An abnormal TSH value needs to be followed up with a free T4 test. Patients with abnormal free T4 values will be excluded. Patients with an elevated TSH and normal free T4 will be allowed if referred to their family doctor for thyroid hormone replacement therapy prior to randomization Kidney disorders 9. Creatinine Clearance: 3X upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3xULN 14. Total bilirubin (TB) >2.0 mg/dL (>34.2 µmol/L) 15. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody 16. History of drug-induced liver enzyme elevations 17. History of severe hepatobiliary disease or hepatotoxicity with any medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.;Secondary Objective: For each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin vs. placebo: percentage change from baseline in body weight after 16 weeks of double-blind treatment. change from baseline in fasting plasma glucose (FPG) after 1 week of double-blind treatment Change from baseline in FPG after 16 weeks if treatment. Comparison of proportion of patients with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) after 16 weeks of double-blind treatment, in patients who had HbA1c =7.0% at baseline. ;Primary end point(s): Change from baseline in HbA1c. | — |
Countries
Germany, Hungary, Slovakia
Outcome results
None listed