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NCT00481117 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481117
Other study ID # 11719
Secondary ID I1K-MC-GLUD
Status Completed
Phase Phase 1
First received May 31, 2007
Last updated September 10, 2010
Start date August 2008
Est. completion date December 2008

Study information
Verified date September 2010
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 37
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• LY2405319

• Placebo

Locations
Country Name City State
India 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. Ambawadi
India 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. Bangalore
India 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. Belgaum
India 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. Hyderabaad
India 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. Maharashtra
India 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. Rabale
India 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. Siddhapudur
Mexico 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. Mexico City
Mexico 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. Morelia
New Zealand 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. Wellington
South Africa 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

India,  Mexico,  New Zealand,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety labs, ECGs, vital signs, adverse events. End of dosing period
Secondary Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples) End of dosing period
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