Clinical trial NCT00065312: An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-07-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
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state: Washington
Study officials:
References: