Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00519142
Last Updated: 2009-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
367 participants
INTERVENTIONAL
2007-08-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
metformin + placebo for mitiglinide
placebo for mitiglinide
three times a day with meals
2
metformin + mitiglinide three times a day with meals
mitiglinide
three times a day with meals
3
metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
mitiglinide
two times a day with meals
Interventions
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placebo for mitiglinide
three times a day with meals
mitiglinide
three times a day with meals
mitiglinide
two times a day with meals
Eligibility Criteria
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Inclusion Criteria
* stable metformin usage for at least 4 months
* HbA1c 7.5% - 10.5% inclusive
* no severe diabetic complications
Exclusion Criteria
* use of oral diabetic agent within 12 weeks
* acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
18 Years
75 Years
ALL
No
Sponsors
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Elixir Pharmaceuticals
INDUSTRY
Responsible Party
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Elixir Pharmaceuticals
Principal Investigators
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Paul Martha, MD
Role: STUDY_DIRECTOR
Elixir Pharmaceuticals
Locations
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Elixir Study Site
Glendale, Arizona, United States
Elixir Study Site
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(s)
Oakland Area, California, United States
Elixir Study Site
Orange, California, United States
Elixir Study Site
West Hills, California, United States
Elixir Study Site
Westlake Village, California, United States
Elixir Study Site
Pueblo, Colorado, United States
Elixir Study Site(s)
Washington D.C., District of Columbia, United States
Elixir Study Site
Chiefland, Florida, United States
Elixir Study Site
Coral Gables, Florida, United States
Elixir Study Site
Kissimmee, Florida, United States
Elixir Study Site(s)
Miami, Florida, United States
Elixir Study Site
Saint Cloud, Florida, United States
Elixir Study Site
Winter Park, Florida, United States
Elixir Study Site
Atlanta, Georgia, United States
Elixir Study Site
Austell, Georgia, United States
Elixir Study Site
Perry, Georgia, United States
Elixir Study Site(s)
Chicago, Illinois, United States
Elixir Study Site
Wichita, Kansas, United States
Elixir Study Site
Kansas City, Missouri, United States
Elixir Study Site
St Louis, Missouri, United States
Elixir Study Site
Las Vegas, Nevada, United States
Elixir Study Site
Hamilton, New Jersey, United States
Elixir Study Site
Hillsborough, New Jersey, United States
Elixir Study Site
Sewell, New Jersey, United States
Elixir Study Site(s)
New York, New York, United States
Elixir Study Site
Mooresville, North Carolina, United States
Elixir Study Site
Morehead City, North Carolina, United States
Elixir Study Site
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
Medford, Oregon, United States
Elixir Study Site
Harleysville, Pennsylvania, United States
Elixir Study Site
Levittown, Pennsylvania, United States
Elixir Study Site
Uniontown, Pennsylvania, United States
Elixir Study Site
Columbia, South Carolina, United States
Elixir Study Site
Simpsonville, South Carolina, United States
Elixir Study Site
Memphis, Tennessee, United States
Elixir Study Site
Tullahoma, Tennessee, United States
Elixir Study Site(s)
Dallas, Texas, United States
Elixir Study Site
El Paso, Texas, United States
Elixir Study Site(s)
Fort Worth, Texas, United States
Elixir Study Site(s)
Houston, Texas, United States
Elixir Study Site
Humble, Texas, United States
Elixir Study Site
Midland, Texas, United States
Elixir Study Site
New Braunfels, Texas, United States
Elixir Study Site
North Richland Hills, Texas, United States
Elixir Study Site
Pearland, Texas, United States
Elixir Study Site
Plano, Texas, United States
Elixir Study Site(s)
San Antonio, Texas, United States
Elixir Study Site
Temple, Texas, United States
Elixir Study Site
Norfolk, Virginia, United States
Elixir Study Site
Federal Way, Washington, United States
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, , Puerto Rico
Countries
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Other Identifiers
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EX-1510-CT-003
Identifier Type: -
Identifier Source: org_study_id
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