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

NCT00525330 ↗

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

EvaluationDrugModalityDoseRoute
Subject BISEGLIPTIN Small molecule 60 mg —
Subject BISEGLIPTIN Small molecule 120 mg —
Comparator Metformin Small molecule — —