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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Glimepiride; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)

1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication

2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications

• Accept treatment with metformin and glimepiride throughout the study, as per protocol

• Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.

• Stable weight for 3 months prior to screening

• Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

• Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion Criteria:

• Type 1 Diabetes

• HbA1c equal to or less than 6.5 at randomization

• Chronic insulin use

• Taking drugs to promote weight loss by prescription or over the counter

• Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled

• History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening

• Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility

• Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit

• Acute or chronic pancreatitis of any form

• Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)

• History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer

• A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening

• Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

• History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years

• Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing

• Organ transplant except cornea

• Have enrolled in another clinical trial within the last 30 days

• Have previously signed an informed consent or participated in a LY2189265 study

• Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening