Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elixir Pharmaceuticals
• Treatments: Metformin; Mitiglinide

Criteria

Inclusion Criteria:

• type 2 diabetes diagnosed for at least 6 months

• stable metformin usage for at least 4 months

• HbA1c 7.5% - 10.5% inclusive

• no severe diabetic complications

Exclusion Criteria:

• chronic insulin use

• use of oral diabetic agent within 12 weeks

• acute or chronic conditions, excluding diabetes, that could compromise end point evaluation