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NCT00519142 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00519142
Other study ID # EX-1510-CT-003
Secondary ID
Status Completed
Phase Phase 3
First received August 20, 2007
Last updated September 16, 2009
Start date August 2007
Est. completion date October 2008

Study information
Verified date September 2009
Source Elixir Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 367
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo for mitiglinide
three times a day with meals
• mitiglinide
three times a day with meals
• mitiglinide
two times a day with meals

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

Sponsors (1)
Lead Sponsor Collaborator
Elixir Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline in HbA1c after 24 weeks of treatment No
Secondary change from baseline in 2-hour post-prandial glucose after 24 weeks of treatment No
Secondary change from baseline in fasting plasma glucose after 24 weeks of treatment No
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