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Completed

NCT Number: NCT00461617

Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients

The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy

Exclusion criteria

  • Type 1 diabetes patients
  • Patients who require treatment with insulin
  • Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
  • Patients with severe ketosis, diabetic coma or precoma
  • Patients complicated with severe hepatic diseases
  • Patients complicated with severe renal diseases
  • Patients complicated with severe hypertension
  • Patients complicated with severe cardiac disease
  • Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period

Treatment and study plan

Mitiglinide

Drug

10mg tablet, 10mg TID

Other names: Glufast

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: -2, 0, 4, 8, 10, 12, 16, 20 week

Secondary outcomes

  1. Fasting plasma glucose level (FPG)

    Time frame: 0, 4, 8, 12, 16, 20 week

  2. Two-hour postprandial glucose level (PPG2)

    Time frame: 0, 12, 20 week

  3. One-hour postprandial glucose level (PPG1)

    Time frame: 0, 12, 20 week

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2007
Registry last updated
Oct 21, 2008

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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