Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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