Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Ajinomoto USA, INC.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189774
First received: September 13, 2005
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to investigate the superiority of nateglinide over placebo for inadequately controlled type 2 diabetic patients with pioglitazone treatment.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type II
Drug: nateglinide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus under the treatment with pioglitazone

Exclusion Criteria:

  • Patients who cannot follow the diet therapy and/or exercise therapy
  • Type 1 diabetes mellitus
  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: NCT00189774

Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Ajinomoto USA, INC.
Investigators
Study Director: Study Director Astellas Pharma Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189774     History of Changes
Other Study ID Numbers: 026-CL-004
Study First Received: September 13, 2005
Last Updated: March 11, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
nateglinide
pioglitazone
combination drug therapy
treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nateglinide
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014