Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial
| NCT number | NCT00065312 |
| Other study ID # | 5837 |
| Secondary ID | H7R-MC-GCBD |
| Status | Completed |
| Phase | Phase 2 |
| First received | July 21, 2003 |
| Last updated | July 18, 2006 |
| Verified date | July 2006 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Primary Purpose: Treatment
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| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
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