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

September 16, 2009 updated by: Elixir Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Elixir Study Site
      • Fajardo, Puerto Rico, 00738
        • Elixir Study Site
      • Ponce, Puerto Rico
        • Elixir Study Site(s)
      • San Juan, Puerto Rico
        • Elixir Study Site(s)
  • United States
    • Arizona
      • Glendale, Arizona, United States
        • Elixir Study Site
    • California
      • Greenbrae, California, United States
        • Elixir Study Site
      • La Jolla, California, United States
        • Elixir Study Site
      • Los Angeles, California, United States
        • Elixir Study Site
      • Los Gatos, California, United States
        • Elixir Study Site
      • Oakland Area, California, United States
        • Elixir Study Site(s)
      • Orange, California, United States
        • Elixir Study Site
      • West Hills, California, United States, 91307
        • Elixir Study Site
      • Westlake Village, California, United States
        • Elixir Study Site
    • Colorado
      • Pueblo, Colorado, United States
        • Elixir Study Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Elixir Study Site(s)
    • Florida
      • Chiefland, Florida, United States, 32626
        • Elixir Study Site
      • Coral Gables, Florida, United States
        • Elixir Study Site
      • Kissimmee, Florida, United States
        • Elixir Study Site
      • Miami, Florida, United States
        • Elixir Study Site(s)
      • St. Cloud, Florida, United States
        • Elixir Study Site
      • Winter Park, Florida, United States
        • Elixir Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30080
        • Elixir Study Site
      • Austell, Georgia, United States
        • Elixir Study Site
      • Perry, Georgia, United States
        • Elixir Study Site
    • Illinois
      • Chicago, Illinois, United States
        • Elixir Study Site(s)
    • Kansas
      • Wichita, Kansas, United States
        • Elixir Study Site
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Elixir Study Site
      • St Louis, Missouri, United States, 63110
        • Elixir Study Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Elixir Study Site
    • New Jersey
      • Hamilton, New Jersey, United States
        • Elixir Study Site
      • Hillsborough, New Jersey, United States
        • Elixir Study Site
      • Sewell, New Jersey, United States
        • Elixir Study Site
    • New York
      • New York, New York, United States
        • Elixir Study Site(s)
    • North Carolina
      • Mooresville, North Carolina, United States
        • Elixir Study Site
      • Morehead City, North Carolina, United States
        • Elixir Study Site
    • Ohio
      • Akron, Ohio, United States
        • Elixir Study Site
      • Cincinnati, Ohio, United States
        • Elixir Study Site
      • Gallipolis, Ohio, United States
        • Elixir Study Site
      • Kettering, Ohio, United States
        • Elixir Study Site
    • Oregon
      • Medford, Oregon, United States
        • Elixir Study Site
    • Pennsylvania
      • Harleysville, Pennsylvania, United States
        • Elixir Study Site
      • Levittown, Pennsylvania, United States
        • Elixir Study Site
      • Uniontown, Pennsylvania, United States
        • Elixir Study Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Elixir Study Site
      • Simpsonville, South Carolina, United States
        • Elixir Study Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Elixir Study Site
      • Tullahoma, Tennessee, United States
        • Elixir Study Site
    • Texas
      • Dallas, Texas, United States
        • Elixir Study Site(s)
      • El Paso, Texas, United States
        • Elixir Study Site
      • Fort Worth, Texas, United States
        • Elixir Study Site(s)
      • Houston, Texas, United States
        • Elixir Study Site(s)
      • Humble, Texas, United States
        • Elixir Study Site
      • Midland, Texas, United States
        • Elixir Study Site
      • N. Richland Hills, Texas, United States
        • Elixir Study Site
      • New Braunfels, Texas, United States
        • Elixir Study Site
      • Pearland, Texas, United States
        • Elixir Study Site
      • Plano, Texas, United States, 75074
        • Elixir Study Site
      • San Antonio, Texas, United States
        • Elixir Study Site(s)
      • Temple, Texas, United States
        • Elixir Study Site
    • Virginia
      • Norfolk, Virginia, United States
        • Elixir Study Site
    • Washington
      • Federal Way, Washington, United States
        • Elixir Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
metformin + placebo for mitiglinide
Drug: placebo for mitiglinide
three times a day with meals
Experimental: 2
metformin + mitiglinide three times a day with meals
Drug: mitiglinide
three times a day with meals
Drug: mitiglinide
two times a day with meals
Experimental: 3
metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
Drug: mitiglinide
three times a day with meals
Drug: mitiglinide
two times a day with meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in HbA1c
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in 2-hour post-prandial glucose
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment
change from baseline in fasting plasma glucose
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elixir Pharmaceuticals

Investigators

  • Study Director: Paul Martha, MD, Elixir Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 16, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-1510-CT-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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