Type 2 Diabetes
Conditions
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.
Interventions
DRUGLY2405319
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety labs, ECGs, vital signs, adverse events. | End of dosing period |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples) | End of dosing period |
Countries
India, Mexico, New Zealand, South Africa
Outcome results
None listed