Back to resultsSafety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY2405319
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Outcomes
Primary Outcome Measures
Safety labs, ECGs, vital signs, adverse events.
Secondary Outcome Measures
Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00481117
Brief Title
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Official Title
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LY2405319
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety labs, ECGs, vital signs, adverse events.
Time Frame
End of dosing period
Secondary Outcome Measure Information:
Title
Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)
Time Frame
End of dosing period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Ambawadi
ZIP/Postal Code
380015
Country
India
Facility Name
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.
City
Bangalore
ZIP/Postal Code
560 078
Country
India
Facility Name
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.
City
Belgaum
ZIP/Postal Code
590 010
Country
India
Facility Name
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.
City
Hyderabaad
ZIP/Postal Code
500004
Country
India
Facility Name
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.
City
Maharashtra
ZIP/Postal Code
422 002
Country
India
Facility Name
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.
City
Rabale
ZIP/Postal Code
400 7001
Country
India
Facility Name
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.
City
Siddhapudur
ZIP/Postal Code
641 044
Country
India
Facility Name
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.
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
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.
City
Morelia
ZIP/Postal Code
CP 58249
Country
Mexico
Facility Name
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.
City
Wellington
Country
New Zealand
Facility Name
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.
City
George
ZIP/Postal Code
6529
Country
South Africa
12. IPD Sharing Statement
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Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
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