Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Elixir Pharmaceuticals
Information provided by:	Elixir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00519142

Purpose

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Mitiglinide Metformin Metformin hydrochloride

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519142

Show 61 Study Locations

Sponsors and Collaborators

Elixir Pharmaceuticals

Investigators

Study Director:

Paul Martha, MD

Elixir Pharmaceuticals

More Information

No publications provided

Responsible Party:	Paul Martha, Chief Medical Officer, Elixir Pharmaceuticals
ClinicalTrials.gov 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

Mitiglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012