Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments ly2944876, exenatide extended-release, placebo
Phase phase 2
Sponsor Eli Lilly and Company
Start date April 2014
End date August 2015
Trial size 375 participants
Trial identifier NCT02119819, 15062, 2013‐003552‐21, I7I-MC-XNAA

Summary

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants involvement in the study is expected to last about 30 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Dose 1 of LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
ly2944876
Administered SC
(Experimental)
Dose 2 of LY2944876 given SC once weekly for 24 weeks.
ly2944876
Administered SC
(Experimental)
Dose 3 of LY2944876 given SC once weekly for 24 weeks.
ly2944876
Administered SC
(Experimental)
Dose 4 of LY2944876 given SC once weekly for 24 weeks.
ly2944876
Administered SC
(Experimental)
2 milligrams (mg) exenatide extended-release given SC once weekly for 24 weeks.
exenatide extended-release
Administered SC
(Placebo Comparator)
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
placebo
Administered SC

Primary Outcomes

Measure
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12
time frame: Baseline, Week 12

Secondary Outcomes

Measure
Change from Baseline in HbA1c at Week 24
time frame: Baseline, Week 24
Mean Percent Change from Baseline in Body Weight
time frame: Baseline, Week 12, Week 24
Change from Baseline in Fasting Blood Glucose
time frame: Baseline, Week 12, Week 24
Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
time frame: Baseline, Week 12, Week 24
Change from Baseline in Lipids
time frame: Baseline, Week 24
Change from Baseline in Fasting Fibroblast Growth Factor 21
time frame: Baseline, Week 12, Week 24
Percentage of Participants Requiring Rescue Therapy
time frame: Baseline through Therapy Completion (Week 24)
Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 or Polyethylene Glycol
time frame: Baseline through Therapy Completion (Week 24)
Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876
time frame: Baseline through Therapy Completion (Week 24)
Change from Baseline in Adiponectin Levels
time frame: Baseline, Week 12, Week 24
Change from Baseline in Beta-Hydroxy Butyrate Levels
time frame: Baseline, Week 12, Week 24
Change from Baseline in Glucagon Levels
time frame: Baseline, Week 12, Week 24
Change from Baseline in Insulin Levels
time frame: Baseline, Week 12, Week 24
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
time frame: Time Frame: Baseline through Therapy Completion (Week 24)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Men or women with diabetes mellitus Type 2 - Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening - Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening Exclusion Criteria: - Women of child bearing potential - Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months - Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year - Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)

Additional Information

Official title Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
Description The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.