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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189774
First Posted: September 19, 2005
Last Update Posted: March 13, 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.
Collaborator:
Ajinomoto USA, INC.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00189774     History of Changes
Other Study ID Numbers: 026-CL-004
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: March 13, 2008
Last Verified: March 2008

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
Pioglitazone
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs