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

NCT00519142 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2009-09-17

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

  • Elixir Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Paul Martha, MD · Elixir Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00519142 on ClinicalTrials.gov