Here is another trial just started by Lilly for its own GLP-1 Once Weekly Diabetes drug which could one day compete with Exenatide Once Weekly. So what's Lilly's intentions and motives ?


A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
This study is not yet open for participant recruitment.
Verified by Eli Lilly and Company, October 2009
First Received: October 22, 2009 No Changes Posted
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01001104
Purpose

The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2189265
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Metabolic Disorders
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

* Change in glycosylated hemoglobin (HbA1c) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
* Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
* Change in fasting blood glucose values (FBG) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
* Change in mean daily blood glucose (based on Self monitoring blood glucose) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
* Change in total body weight from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
* Change from baseline in insulin sensitivity (HOMA2-S) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
* Change from baseline in Beta-cell function (HOMA2-B) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
* Pharmacokinetics Cmax [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
* Incidence of Self-reported hypoglycemic episodes [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment: 144
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
0.75mg LY2189265: Experimental Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
0.5mg LY2189265: Experimental Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
0.25mg LY2189265: Experimental Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
Placebo: Placebo Comparator Drug: Placebo
Administered by subcutaneous injection, once weekly for 12 weeks