drugset / Trial / NCT00525330
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
RandomizedParallel-groupTriple-blindTreatment
Summary
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-08
- Completion
- 2008-08
Outcome
Met primary endpoint
release “フェーズ2a臨床試験(於:米国、インド)を実施してまいりましたが、この度、各々の臨床試験が終了し、主要な評価項目において目標とする結果を得ることができました。” kyorin-pharm.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BISEGLIPTIN | Small molecule | 60 mg | — |
| Subject | BISEGLIPTIN | Small molecule | 120 mg | — |
| Comparator | Metformin | Small molecule | — | — |