A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

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

Details

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

Criteria

Inclusion Criteria:

• Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO] Classification of Diabetes).

• Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label.

• Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin.

• Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%.

• Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding.

• Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening.

• Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2), inclusive.

• Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary.

Exclusion Criteria:

• Have type 1 diabetes mellitus.

• Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs.

• Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening.

• Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery.

• Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke.

• Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.

• Have a problem with the liver or pancreas.

• Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality.

• Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening.

• Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.

• Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.

• Have had an organ transplant except for corneal transplant.

• Have received treatment within the last 30 days with a drug which has not been regulatory approved.

• Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening.

• Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes.

• Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples.

• Have previously participated or signed an informed consent document for this same type of study and study drug.