A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT02111096

Run by

Eli Lilly and Company

People needed

174

Starts

2014-04-01

Expected to finish

2015-09-01

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• John Muir Health Network - The Osteoporosis Center — Concord, California, United States
• Valley Endocrine, Fresno — Fresno, California, United States
• National Research Institute — Los Angeles, California, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• University of Hawaii — Honolulu, Hawaii, United States
• East West Medical Institute — Honolulu, Hawaii, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• Midwest CRC — Crystal Lake, Illinois, United States
• Iderc, P.L.C. — Des Moines, Iowa, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• Centex Studies, Inc — Lake Charles, Louisiana, United States
• Cosmopolitan International Diabetes Center — Columbia, Missouri, United States
• Mercy Medical Research Institute — Springfield, Missouri, United States
• Palm Research Center — Las Vegas, Nevada, United States
• SHS Clinical Research Group — Toms River, New Jersey, United States
• Office:Alwine,Lk — Downingtown, Pennsylvania, United States
• University Diabetes and Endocrine Consultants — Chattanooga, Tennessee, United States
• Dallas Diabetes Endocrine Center — Dallas, Texas, United States
• Galenos Research — Dallas, Texas, United States
• San Gabriel Clinical Research — Georgetown, Texas, United States
• Oakwell Clinical Research — San Antonio, Texas, United States
• Victorium Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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