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

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. Identifier: NCT00189774
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 13, 2008
Ajinomoto USA, INC.
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type II Drug: nateglinide Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00189774

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.
Study Director: Study Director Astellas Pharma Inc Identifier: NCT00189774     History of Changes
Other Study ID Numbers: 026-CL-004
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by Astellas Pharma Inc:
combination drug therapy

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