Trial | NCT00519142  Report issue

Title

Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mitiglinide ...

  • Study Participants

    367
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.
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 Started
Aug 31
2007
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Sep 17
2009
Estimate

Drug placebo for mitiglinide

three times a day with meals

Drug mitiglinide

three times a day with meals

Drug mitiglinide

two times a day with meals

1 Placebo Comparator

metformin + placebo for mitiglinide

2 Experimental

metformin + mitiglinide three times a day with meals

3 Experimental

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

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
No Results Posted