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Completed

NCT Number: NCT00519142

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Elixir Study Site, Carolina, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo for mitiglinide

Drug

three times a day with meals

Mitiglinide

Drug

three times a day with meals

Primary outcomes

  1. change from baseline in HbA1c

    Time frame: after 24 weeks of treatment

Secondary outcomes

  1. change from baseline in 2-hour post-prandial glucose

    Time frame: after 24 weeks of treatment

  2. change from baseline in fasting plasma glucose

    Time frame: after 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

Elixir Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2007
Registry last updated
Sep 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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