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An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
This study has been completed.
First Received: July 21, 2003   Last Updated: July 18, 2006   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00065312
  Purpose

The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: naveglitazar
Phase II

Study Type: Interventional
Study Design: Treatment

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes for at least 3 months.
  • Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
  • Diabetes therapy must be unchanged for at least 3 months prior to screening.
  • Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.

Exclusion Criteria:

  • Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
  • Current use of metformin or a sulfonylurea agent in combination.
  • History of liver disease.
  • History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
  • Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065312

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Locations
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Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

Study ID Numbers: 5837, H7R-MC-GCBD
Study First Received: July 21, 2003
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00065312     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Type 2 diabetes

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

ClinicalTrials.gov processed this record on November 25, 2009