A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

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.