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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00519142

Run by

Elixir Pharmaceuticals

People needed

367

Starts

2007-08-01

Expected to finish

2008-10-01

Last updated by the study team

2009-09-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• chronic insulin use
• use of oral diabetic agent within 12 weeks
• acute or chronic conditions, excluding diabetes, that could compromise end point evaluation

Where it is running

• 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 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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