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Januvia dose-ranging study in type 2 diabetes
NCT00482079Phase 2
Key facts
- Status
- Completed
- Start
- May 2003
- Primary completion
- Aug 2004
- Sponsor
- Merck & Co.
- Drugs
- sitagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 2, randomised, double-blind trial of sitagliptin in type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Merck & Co. Primary endpoint: Hemoglobin A1c change from baseline at 12 weeks. Started May 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Januvia
Sitagliptin (MK0431) at various doses (5mg BID to 100mg QD)
Placebo
Placebo control
Glipizide
Active control (glipizide 5mg to 20mg)
03
Endpoints
Primary
Hemoglobin A1c change from baseline
Secondary
Safety and tolerability of MK0431
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