Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
367
2 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Aug 2007
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedSeptember 17, 2009
September 1, 2009
1.2 years
August 20, 2007
September 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in HbA1c
after 24 weeks of treatment
Secondary Outcomes (2)
change from baseline in 2-hour post-prandial glucose
after 24 weeks of treatment
change from baseline in fasting plasma glucose
after 24 weeks of treatment
Study Arms (3)
1
PLACEBO COMPARATORmetformin + placebo for mitiglinide
2
EXPERIMENTALmetformin + mitiglinide three times a day with meals
3
EXPERIMENTALmetformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
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, 91307, 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, 32626, 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, 30080, 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, 64132, United States
Elixir Study Site
St Louis, Missouri, 63110, 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, 75074, 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, 00983, Puerto Rico
Elixir Study Site
Fajardo, 00738, Puerto Rico
Elixir Study Site(s)
Ponce, Puerto Rico
Elixir Study Site(s)
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Martha, MD
Elixir Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 22, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 17, 2009
Record last verified: 2009-09