A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
Status: | Terminated |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 79 |
Updated: | 4/26/2018 |
Start Date: | April 2014 |
End Date: | September 2015 |
A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects With Type 2 Diabetes Mellitus
The intent of this study is to assess the safety of LY2409021 in participants with Type 2
diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal
physician. The study treatment is expected to last 12 months (52 weeks).
diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal
physician. The study treatment is expected to last 12 months (52 weeks).
Inclusion Criteria:
- Have been treated with a stable dose of metformin for at least 3 months and have been
treated with an optimally effective and stable dose of an sulfonylurea for at least 6
months prior to screening.
- HbA1c value between 7.0% and 10.0%, inclusive.
- Body mass index (BMI) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.
Exclusion Criteria:
- Known type 1 diabetes mellitus.
- More than 1 episode of severe hypoglycemia within 6 months prior to screening.
- Two or more emergency room visits or hospitalizations due to poor glucose control in
the 6 months prior to screening.
- Severe gastrointestinal disease that may significantly impact gastric emptying or
motility or having undergone gastric bypass or gastric banding surgery.
- Previous history or active diagnosis of pancreatitis.
- Positive hepatitis B surface antigen or hepatitis C antibody.
- Clinical signs or symptoms of liver disease, or hepatic aminotransferases
(aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal
(ULN) or elevated alkaline phosphatase (greater than ULN) unrelated to bone metabolic
disease.
- Elevated total bilirubin level (greater than ULN), clinically suspicious
signs/symptoms of cirrhosis or history of cirrhosis.
- Current diagnosis, personal history of neuroendocrine tumors, family history of any
type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau.
- Contraindications for magnetic resonance imaging.
We found this trial at
27
sites
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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