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

Elixir Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo for mitiglinide; Drug: mitiglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519142

EX-1510-CT-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 367 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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367 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

metformin + placebo for mitiglinide

Treatment:

Drug: placebo for mitiglinide

2

Experimental group

Description:

metformin + mitiglinide three times a day with meals

Treatment:

Drug: mitiglinide

Drug: mitiglinide

3

Experimental group

Description:

metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal

Treatment:

Drug: mitiglinide

Drug: mitiglinide