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COMPLETEDPhase 3NCT00519142

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

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 (T...

Lead sponsor: Elixir Pharmaceuticals•57 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Elixir Pharmaceuticals

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.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 17, 2009Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment367

Start dateAug 2007

Last updatedSep 17, 2009

Condition

Diabetes Mellitus, Type 2

Locations shown

Elixir Study Site

Glendale, Arizona

Elixir Study Site

Greenbrae, California

Elixir Study Site

La Jolla, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2009Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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