Type 2 diabetes treated with metformin and not adequately controlled MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Sponsors
sanofi aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged from 35 to 70 years, inclusively, 2. With type 2 Diabetes diagnosed for at least 6 months, 3. Not previously treated with insulin, 4. On metformin for at least 3 months and: - With a stable minimal dose of 1.7 g/day for at least 2 months, - Or if metformin is poorly tolerated, with a stable minimal dose of 1 g/day for at least 2 months, 5. HbA1c = 7 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with oral antidiabetic drugs other than metformin within the last 3 months, 2. Treatment with the combination of metformin + sulfonylurea for more than 1 year, 3. Previous treatment with GLP-1 agonists or DPP IV inhibitors, 4. FPG (assessed by central laboratory measurement) = 280 mg/dL (15.4 mmol/L), 5. Diabetes other than type 2 diabetes, 6. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method), 7. In-patient care, 8. Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, 9. Impaired renal function: serum creatinine = 1.5 mg/dL (= 133 µmol/L) or = 1.4 mg/dL (= 124 µmol/L) in men and women, respectively, 10. History of sensitivity to the study drugs or to drugs with a similar chemical structure, 11. Impaired hepatic function (ALAT, ASAT > 3 x upper limit of normal range), 12. Treatment with systemic corticosteroids within the 3 months prior to study entry or likehood of requiring treatment during the study that are not permitted during the study, 13. Alcohol or drug abuse in the last year, 14. Night shift worker 15. Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient’s safety or limit the patient successful participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of insulin glargine over sitagliptin in reducing HbA1c from baseline to the end of the treatment period.;Secondary Objective: The secondary objectives of this study are to assess the effect of insulin glargine in comparison with sitagliptin on: Efficacy parameters: • HbA1c levels • Fasting Plasma Glucose • 7-point plasma glucose profiles • Percentage of patients with HbA1c <7% and <6.5% Safety parameters: • Hypoglycemia occurrence • Body weight • Overall safety ;Primary end point(s): The primary efficacy variable will be the change in HbA1c from baseline to study endpoint. The study endpoint is defined as the last available HbA1c value measured during the study treatment phase plus 14 days after last dose. | — |
Countries
Austria, Greece, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed