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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: placebo for mitiglinide (Drug); mitiglinide (Drug); mitiglinide (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Elixir Pharmaceuticals

Official(s) and/or principal investigator(s):
Paul Martha, MD, Study Director, Affiliation: Elixir Pharmaceuticals

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: change from baseline in HbA1c

Secondary outcome:

change from baseline in 2-hour post-prandial glucose

change from baseline in fasting plasma glucose

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Elixir Study Site(s), San Juan, Puerto Rico

Elixir Study Site(s), Ponce, Puerto Rico

Elixir Study Site, Fajardo 00738, Puerto Rico

Elixir Study Site, Carolina 00983, Puerto Rico

Elixir Study Site, Glendale, Arizona, United States

Elixir Study Site, Greenbrae, California, United States

Elixir Study Site, Los Gatos, California, United States

Elixir Study Site, La Jolla, California, United States

Elixir Study Site, Los Angeles, California, United States

Elixir Study Site, Westlake Village, California, United States

Elixir Study Site, Orange, California, United States

Elixir Study Site, West Hills, California 91307, United States

Elixir Study Site(s), Oakland Area, California, United States

Elixir Study Site, Pueblo, Colorado, United States

Elixir Study Site(s), Washington, District of Columbia, United States

Elixir Study Site, St. Cloud, Florida, United States

Elixir Study Site, Winter Park, Florida, United States

Elixir Study Site(s), Miami, Florida, United States

Elixir Study Site, Kissimmee, Florida, United States

Elixir Study Site, Coral Gables, Florida, United States

Elixir Study Site, Chiefland, Florida 32626, United States

Elixir Study Site, Perry, Georgia, United States

Elixir Study Site, Austell, Georgia, United States

Elixir Study Site, Atlanta, Georgia 30080, United States

Elixir Study Site(s), Chicago, Illinois, United States

Elixir Study Site, Wichita, Kansas, United States

Elixir Study Site, St Louis, Missouri 63110, United States

Elixir Study Site, Kansas City, Missouri 64132, United States

Elixir Study Site, Las Vegas, Nevada, United States

Elixir Study Site, Hillsborough, New Jersey, United States

Elixir Study Site, Sewell, New Jersey, United States

Elixir Study Site, Hamilton, New Jersey, United States

Elixir Study Site(s), New York, New York, United States

Elixir Study Site, Morehead City, North Carolina, United States

Elixir Study Site, Mooresville, North Carolina, United States

Elixir Study Site, Akron, Ohio, United States

Elixir Study Site, Kettering, Ohio, United States

Elixir Study Site, Cincinnati, Ohio, United States

Elixir Study Site, Gallipolis, Ohio, United States

Elixir Study Site, Medford, Oregon, United States

Elixir Study Site, Levittown, Pennsylvania, United States

Elixir Study Site, Uniontown, Pennsylvania, United States

Elixir Study Site, Harleysville, Pennsylvania, United States

Elixir Study Site, Columbia, South Carolina, United States

Elixir Study Site, Simpsonville, South Carolina, United States

Elixir Study Site, Tullahoma, Tennessee, United States

Elixir Study Site, Memphis, Tennessee, United States

Elixir Study Site(s), San Antonio, Texas, United States

Elixir Study Site, Midland, Texas, United States

Elixir Study Site(s), Houston, Texas, United States

Elixir Study Site(s), Fort Worth, Texas, United States

Elixir Study Site, Humble, 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, Temple, Texas, United States

Elixir Study Site, El Paso, Texas, United States

Elixir Study Site(s), Dallas, Texas, United States

Elixir Study Site, Plano, Texas 75074, United States

Elixir Study Site, Norfolk, Virginia, United States

Elixir Study Site, Federal Way, Washington, United States

Starting date: August 2007
Ending date: October 2008
Last updated: March 18, 2008