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Sitagliptin add-on to voglibose in Japanese T2DM
NCT00837577Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2009
- Primary completion
- Aug 2010
- 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/Sitagliptin with Placebo/Sitagliptin (2 arms). Primary endpoint: Change From Baseline in Hemoglobin A1c at 12 weeks. Started Feb 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sitagliptin/Sitagliptin
Sitagliptin 50mg + Voglibose (0-12w) -> Sitagliptin 50-100mg + Voglibose (12-52w)
Placebo/Sitagliptin
Placebo + Voglibose (0-12w) -> Sitagliptin 50-100mg + Voglibose (12-52w)
03
Who it enrols
Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy. Patients with a history of Type 1 Diabetes Mellitus are excluded.
04
Endpoints
Primary
Change From Baseline in Hemoglobin A1c
Secondary
Change From Baseline in 2-hour Postprandial Glucose
Change From Baseline in Fasting Plasma Glucose
05
Results
Primary endpoints met
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