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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461617
First Posted: April 18, 2007
Last Update Posted: October 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

Condition Intervention Phase
Diabetes Drug: Mitiglinide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Hemoglobin A1C (HbA1C) [ Time Frame: -2, 0, 4, 8, 10, 12, 16, 20 week ]

Secondary Outcome Measures:
  • Fasting plasma glucose level (FPG) [ Time Frame: 0, 4, 8, 12, 16, 20 week ]
  • Two-hour postprandial glucose level (PPG2) [ Time Frame: 0, 12, 20 week ]
  • One-hour postprandial glucose level (PPG1) [ Time Frame: 0, 12, 20 week ]

Enrollment: 291
Study Start Date: August 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Nateglinide 120 mg TID
Drug: Mitiglinide
10mg tablet, 10mg TID
Other Name: Glufast

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461617


Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Xin Gao, Professor Endocrinology Dept. of Fudan University Zhongshan Hospital
  More Information

Responsible Party: Gao Xin/Professor, Zhongshan Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00461617     History of Changes
Other Study ID Numbers: KAD1301
First Submitted: April 17, 2007
First Posted: April 18, 2007
Last Update Posted: October 21, 2008
Last Verified: April 2007

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
diabetes
rapid and short acting insulin secretagogue
α-glucosidase inhibitor
HbA1C
insulin

Additional relevant MeSH terms:
Nateglinide
Mitiglinide
Hypoglycemic Agents
Physiological Effects of Drugs