A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: LY2409021; Drug: Placebo; Drug: Sulfonylurea; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02111096

2013-004275-12 (EudraCT Number)

I1R-MC-GLDJ (Other Identifier)

15286

Details and patient eligibility

About

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).

Enrollment: 174 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 3 patient groups, including a placebo group

LY2409021

Experimental group

Description:

20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Treatment:

Drug: Sulfonylurea

Drug: Metformin

Drug: LY2409021

Sitagliptin

Active Comparator group

Description:

100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Treatment:

Drug: Sulfonylurea

Drug: Metformin

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Treatment:

Drug: Placebo

Drug: Sulfonylurea

Drug: Metformin