At a glance
ClinicalIndex Comparison Record- ✓Completed prior core study LANTU_C_02761 (NCT00751114) through visit 14
- ✓HbA1c ≥7%
- ✓Metformin dose ≥1 g/day, maintained stable throughout prior study
- ✓Able and willing to perform plasma glucose monitoring and complete patient diary
- ✕Use of oral antidiabetic drugs other than metformin and sitagliptin during prior study
- ✕Use of insulin other than insulin glargine during prior study (except emergency use <7 days)
- ✕Pregnancy or lactation
- ✕Active or unstable proliferative retinopathy requiring photocoagulation or vitrectomy in past 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Insulin Glargine, Sitagliptin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 112 participants across 16 sites in 16 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
Oral administration. 100mg film-coated tablets.
Patients continued with metformin as usual oral anti-diabetic treatment.