A Study in Patients With Type 2 Diabetes Mellitus (AWARD-2)
- Registration Number
- CTRI/2010/091/000300
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 837
Type 2 Diabetes not well controlled on 1,2,or 3 oral diabetic medications (at least one of them must be metformin and/or sulfonylurea)
HbA1c greater than or equal to 7 and less than or equal to 11 if taking 1 oral diabetic medication
HbA1c greater than or equal to 7 and less than 10 if on 2 or 3 oral diabetic medications
Able to tolerate minimum dose of 1500 mg metformin a day and glimepiride 4 mg per day.
Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for insulin glargine.
Stable weight for 3 months prior to screening
BMI (body mass index) between 23 and 45 kg/m2
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.
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
GI (stomach) 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 mg/dL for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 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 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 GLP-1 receptor agonist within the 3 months prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c)Timepoint: Baseline, 52 weeks
- Secondary Outcome Measures
Name Time Method