CClinicalTrials.gg
CompletedNCT00481117Updated Sep 13, 2010

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

A Phase 1 interventional study of LY2405319 and Placebo in Type 2 Diabetes, sponsored by Eli Lilly and Company. Completed at 11 sites in 4 countries. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-09-13.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
37 participants (actual)

Interventions

  • DrugLY2405319
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Safety labs, ECGs, vital signs, adverse events.

    Time frame: End of dosing period

Secondary outcomes

  1. Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)

    Time frame: End of dosing period

07

Study locations

11 sites
  • 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, 380015, 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, 560 078, 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, 590 010, 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, 500004, 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, 422 002, 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, 400 7001, 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, 641 044, 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.
    Mexico City, 14050, 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, CP 58249, 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.
    Wellington, 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.
    George, 6529, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00481117
Lead sponsor
Eli Lilly and Company
First posted
Jun 1, 2007
Start date
Aug 2008
Completion
Dec 2008
Last update
Sep 13, 2010

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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