Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes

Lilly

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo

Drug: LY2405319

Study type

Interventional

Funder types

Industry

Identifiers

NCT00481117

11719 (Registry Identifier)

I1K-MC-GLUD (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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