Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
This study was the extension of the LANTU_C_02761 study named EASIE and identified as
NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve
patients treated with metformin and not adequately controlled).
All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had
the possibility to enter this extension study if they met the other inclusion criteria and
did not present with any exclusion criteria.
The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension
study which consisted of a 12-week treatment period.
The objectives of this extension study were:
- To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with
metformin, insulin glargine and sitagliptin in patients not adequately controlled by a
previous treatment with metformin plus either insulin glargine or sitagliptin.
- To assess the effect of insulin glargine in combination with sitagliptin on HbA1c
level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body
weight and overall safety.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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