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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India,   Mexico,   New Zealand,   South Africa
Australia
 
NCT00481117
11719, I1K-MC-GLUD
Yes
Not Provided
Not Provided
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