Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide

Criteria

Inclusion Criteria:

• Diabetes mellitus, type 2

• Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication

• Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)

• Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%

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

• Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.

• Stable weight for 3 months prior to screening

Exclusion Criteria:

• Diabetes mellitus, type 1

• Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening

• Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)

• Use of medications (prescription or over-the counter) to promote weight loss

• Chronic (>2 weeks) use of systemic glucocorticoid therapy

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

• Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release [SR])

• Cardiovascular event within 6 months prior to screening

• Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)

• Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease

• Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal

• Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening

• Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening

• Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance <60 milliliter (mL)/minute which are determined by central labs at the time of screening

• Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)

• Significant active, uncontrolled endocrine or autoimmune abnormality

• History of a transplanted organ (corneal transplants are allowed)

• Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

• Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol

• Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)

• Sponsor employees

• Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

• Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study

• Have previously completed or withdrawn from this study after providing informed consent