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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00481117




Registration number
NCT00481117
Ethics application status
Date submitted
31/05/2007
Date registered
1/06/2007
Date last updated
13/09/2010

Titles & IDs
Public title
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Scientific title
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
I1K-MC-GLUD
Secondary ID [2] 0 0
11719
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY2405319
Treatment: Drugs - Placebo

Treatment: Drugs: LY2405319


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety labs, ECGs, vital signs, adverse events.
Timepoint [1] 0 0
End of dosing period
Secondary outcome [1] 0 0
Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)
Timepoint [1] 0 0
End of dosing period

Eligibility
Key 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
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Ambawadi
Country [2] 0 0
India
State/province [2] 0 0
Bangalore
Country [3] 0 0
India
State/province [3] 0 0
Belgaum
Country [4] 0 0
India
State/province [4] 0 0
Hyderabaad
Country [5] 0 0
India
State/province [5] 0 0
Maharashtra
Country [6] 0 0
India
State/province [6] 0 0
Rabale
Country [7] 0 0
India
State/province [7] 0 0
Siddhapudur
Country [8] 0 0
Mexico
State/province [8] 0 0
Mexico City
Country [9] 0 0
Mexico
State/province [9] 0 0
Morelia
Country [10] 0 0
New Zealand
State/province [10] 0 0
Wellington
Country [11] 0 0
South Africa
State/province [11] 0 0
George

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00481117
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries