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

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ClinicalTrials.gov Identifier: NCT00461617
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Drug: Mitiglinide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nateglinide
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
Nateglinide 120 mg TID
Drug: Mitiglinide
10mg tablet, 10mg TID
Other Name: Glufast



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

Secondary Outcome Measures :
  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 ]


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

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

Responsible Party: Gao Xin/Professor, Zhongshan Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00461617     History of Changes
Other Study ID Numbers: KAD1301
First Posted: April 18, 2007    Key Record Dates
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