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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00461617
First received: April 17, 2007
Last updated: October 20, 2008
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose level (FPG) [ Time Frame: 0, 4, 8, 12, 16, 20 week ] [ Designated as safety issue: No ]
  • Two-hour postprandial glucose level (PPG2) [ Time Frame: 0, 12, 20 week ] [ Designated as safety issue: No ]
  • One-hour postprandial glucose level (PPG1) [ Time Frame: 0, 12, 20 week ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461617

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

No publications provided

Responsible Party: Gao Xin/Professor, Zhongshan Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00461617     History of Changes
Other Study ID Numbers: KAD1301
Study First Received: April 17, 2007
Last Updated: October 20, 2008
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nateglinide
Mitiglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014