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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 753

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).
-Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
-Have 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 kg/m2, inclusive.
-Are well-motivated, capable, and willing to: a)perform SMBG testing; b)learn how to self-inject treatment (LY2189265 or placebo)and c)maintain a study diary.

Exclusion Criteria

-You have type 1 diabetes mellitus
-You 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 more than 3 months prior to screening is allowable, b)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) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or f)illegal drugs.
-You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
-You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
-You have had problems with your 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.
-You have a serum creatinine result which shows a greater than or equal to 1.5 mg/dL for men or greater than or equal to 1.4 mg/dL for women.
-You have a problem with your liver or pancreas.
-You have creatinine clearance result which shows less than 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
-You have a serum calcitonin test and it shows a greater than or equal to 20 pcg/mL at the time of screening.
-You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
-You have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.
-You have had an organ transplant except for corneal transplant.
-You have received treatment within the last 30 days with a drug which has not been regulatory approved.
-You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
-You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
-You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
-You have previously participated or signed an informed consent document for this same type of study and study drug.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to 26 weeks endpoint (1.5mg LY2189265 compared to metformin)Timepoint: Baseline, 26 weeks

Secondary Outcome Measures

Name	Time	Method