Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT00481117
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes.
- Detailed Description
Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4 dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg.
Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days, and will receive the dose level determined to be the most well tolerated in Part 1.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Men and women without child bearing capability
- Ages 35 to 70 years
- Type 2 diabetic subjects, diagnosed for at least 3 months
- Average body weight (relative to height)
- Willing to be available for the duration of the study
- Significant medical illnesses (except Type 2 diabetes)
- Abnormal 12-lead electrocardiogram (ECG )
- Current or previous use of insulin for greater than 7 days for control of diabetes
- Regular use of drugs of abuse
- Excessive alcohol use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety labs, ECGs, vital signs, adverse events. End of dosing period
- Secondary Outcome Measures
Name Time Method Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples) End of dosing period
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇿🇦George, South Africa