Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are
planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess
dose-dependent effect of this new compound on blood glucose over a period of 12 weeks.
Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure.
Several other attributes of glycemic control and endocrine function of pancreas will be
assessed as secondary objectives. These secondary objectives will be used to compare the
effect of the experimental compound and placebo. Since LY2189265 is in early phase of
development, comprehensive safety assessment is planned to learn more about possible
side-effects and to establish benefit/risk profile of individual doses of the drug. The
trial is organized in four phases: screening, lead-in period to establish baseline status of
participants in each group, treatment period during which participants will be randomized
into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive
placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265
or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue
intervention was allowed after randomization for those participants whose hyperglycemia
reached pre-defined unacceptable high values. Participants on rescue therapy remained in the
study and continued to receive study drug. Participants who received rescue therapy were
included in the analysis population, but only measurements obtained prior to the beginning
of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose
finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3
discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of
participants and the short treatment duration.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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