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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
367

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
change from baseline in HbA1c
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elixir Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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