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

This study has been completed.
Sponsor:
Information provided by:
Elixir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00519142
First received: August 20, 2007
Last updated: September 16, 2009
Last verified: September 2009

August 20, 2007
September 16, 2009
August 2007
October 2008   (final data collection date for primary outcome measure)
change from baseline in HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Improvement in HbA1c [ Time Frame: after 24 weeks of treatment ]
Complete list of historical versions of study NCT00519142 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: placebo for mitiglinide
    three times a day with meals
  • Drug: mitiglinide
    three times a day with meals
  • Drug: mitiglinide
    two times a day with meals
  • Placebo Comparator: 1
    metformin + placebo for mitiglinide
    Intervention: Drug: placebo for mitiglinide
  • Experimental: 2
    metformin + mitiglinide three times a day with meals
    Intervention: Drug: mitiglinide
  • Experimental: 3
    metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
    Intervention: Drug: mitiglinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00519142
EX-1510-CT-003
No
Paul Martha, Chief Medical Officer, Elixir Pharmaceuticals
Elixir Pharmaceuticals
Not Provided
Study Director: Paul Martha, MD Elixir Pharmaceuticals
Elixir Pharmaceuticals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP