A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | April 2014 |
End Date: | October 2015 |
Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
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.
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.
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.
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.
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)
We found this trial at
32
sites
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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