Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.
This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in
Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses
of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to
26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3
portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if
2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin
(HbA1c) at 52 weeks. The final endpoint is 104 weeks.
Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265
doses until a dose decision is made based on quantitative analysis of the benefits and risks
of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for
change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic
blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this
end. After the dose decision, participants in the selected LY2189265 arms and the comparator
arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional
participants will be randomized to the selected and comparator arms. Regardless of the
timing of randomization relative to the dose decision point, all participants in the
selected and comparator arms are planned to receive treatment for 104 weeks; participants in
the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by
Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected
and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will
remain blinded to their study treatment throughout the study. Participants in the
non-selected arms will discontinue from the study after the dose decision
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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