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

This study has been completed.
Information provided by:
Elixir Pharmaceuticals Identifier:
First received: August 20, 2007
Last updated: September 16, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: placebo for mitiglinide
Drug: mitiglinide
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Elixir Pharmaceuticals:

Primary Outcome Measures:
  • change from baseline in HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in 2-hour post-prandial glucose [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • change from baseline in fasting plasma glucose [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 367
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
metformin + placebo for mitiglinide
Drug: placebo for mitiglinide
three times a day with meals
Experimental: 2
metformin + mitiglinide three times a day with meals
Drug: mitiglinide
three times a day with meals
Experimental: 3
metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
Drug: mitiglinide
two times a day with meals

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00519142

  Show 61 Study Locations
Sponsors and Collaborators
Elixir Pharmaceuticals
Study Director: Paul Martha, MD Elixir Pharmaceuticals
  More Information

Responsible Party: Paul Martha, Chief Medical Officer, Elixir Pharmaceuticals Identifier: NCT00519142     History of Changes
Other Study ID Numbers: EX-1510-CT-003 
Study First Received: August 20, 2007
Last Updated: September 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016