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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00481117
First received: May 31, 2007
Last updated: September 10, 2010
Last verified: September 2010

May 31, 2007
September 10, 2010
August 2008
Not Provided
Safety labs, ECGs, vital signs, adverse events. [ Time Frame: End of dosing period ]
Same as current
Complete list of historical versions of study NCT00481117 on ClinicalTrials.gov Archive Site
Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples) [ Time Frame: End of dosing period ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: LY2405319
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2008
Not Provided

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India,   Mexico,   New Zealand,   South Africa
 
NCT00481117
11719, I1K-MC-GLUD
Yes
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP