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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: placebo for mitiglinide; Drug: mitiglinide

• Registration Number: NCT00519142
• Lead Sponsor: Elixir Pharmaceuticals

Brief 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.

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-22
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-09
• Disposition First Submitted: 2009-09-16
• Disposition First Submitted QC: 2009-09-16
• Last Update Submitted: 2009-09-16
• Disposition First Posted: 2009-09-17
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo for mitiglinide	metformin + placebo for mitiglinide
2	mitiglinide	metformin + mitiglinide three times a day with meals
3	mitiglinide	metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal

Primary Outcome Measures

Name	Time	Method
change from baseline in HbA1c	after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
change from baseline in 2-hour post-prandial glucose	after 24 weeks of treatment
change from baseline in fasting plasma glucose	after 24 weeks of treatment

Trial Locations

Locations (2)

Elixir Study Site; 🇵🇷 Fajardo, Puerto Rico

Elixir Study Site(s); 🇵🇷 San Juan, Puerto Rico