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Sitagliptin Insulin-Sparing Efficacy in Type 2 Diabetes
NCT01462266Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2012
- Primary completion
- Jun 2013
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- sitagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Sitagliptin Arm with Placebo Arm (2 arms). Primary endpoint: Change From Baseline in Daily Insulin Dose at Week 24. Started Jan 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sitagliptin Arm
Sitagliptin 100 mg + Insulin Glargine (+/- Metformin)
Placebo Arm
Placebo + Insulin Glargine (+/- Metformin)
03
Endpoints
Primary
Change From Baseline in Daily Insulin Dose at Week 24
Secondary
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study
Time to Achieve the Fasting Glucose Target
04
Results
Primary endpoints met
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