NCT02143765

Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus

An Open, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Mitiglinide Versus Acarbose in Patients With Type 2 Diabetes Mellitus in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control. This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.

Detailed description

Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Mitiglinide	three times a day, orally, for 12 weeks
DRUG	Acarbose	three times a day, orally, for 12 weeks

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-05-21
• Last updated: 2016-07-14

Locations

6 sites across 1 country: China