A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: Berry Consultants; Tessella Inc.; United BioSource Corporation; United BioSource, LLC
• Treatments: Dulaglutide; Metformin; Pharmaceutical Solutions; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Diabetes mellitus, type 2, for at least 6 months

• Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.

• Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of >8.0% to ≤9.5%

• Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m^2), inclusive

• Stable weight for 3 months prior to screening

• Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method

Exclusion Criteria:

• Diabetes mellitus, type 1

• Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin

• Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility

• Use of medications to promote weight loss

• Clinically-relevant cardiovascular event within 6 months prior to screening

• Poorly controlled hypertension

• Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease

• Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels >3.0 times the upper limit of normal

• Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance <60 milliliters per minute (mL/minute)

• Uncontrolled diabetes, defined as >2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.

• Uncontrolled endocrine or autoimmune abnormality

• History of a transplanted organ

• Chronic use of systemic glucocorticoid therapy

• Active or untreated malignancy

• Use of central nervous system (CNS) stimulants