Lantus Versus Levemir Treat-To-Target
Summary
Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c \< 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: * To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c \< 7% and \< 6.5% at the end of the treatment period * To compare the changes in HbA1c and fasting plasma glucose (FPG) * To compare the evolution of blood glucose profiles * To compare the day to day FPG variability, the insulin doses * To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets * To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) * To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL \[3.9 mmol/L\]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL * To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio * To assess the quality of life and treatment satisfaction
Timeline
- Start
- 2006-11
- Primary completion
- 2008-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |