None listed
Conditions
Interventions
Intervention1: LY2189265: 0.75 or 1.5 mg, Administered as subcutaneous injection, once weekly for 78 weeks
Control Intervention1: Insulin Glargine: Administered as subcutaneous injection with dose tit
Sponsors
Eli Lilly
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c)Timepoint: Baseline, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to 26 weeks and 78 weeks endpoint in glycosylated hemoglobin (HbA1c)Timepoint: Baseline, 26 weeks and 78 weeks;Change from baseline to 26, 52 and 78 weeks for blood glucose values from the 8-point self-monitored blood glucose (SMGB), profilesTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks for body weightTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks in the EuroQol 5 DimensionTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Activities of Daily LivingTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Self-PerceptionTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks in the Low Blood Sugar SurveyTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks on blood pressureTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks on electrocardiogram parametersTimepoint: 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks on pancreatic enzymesTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 26, 52 and 78 weeks on serum calcitoninTimepoint: Baseline, 26, 52 and 78 weeks;Change from baseline to 52 and 78 weeks in glucagon concentrationTimepoint: Baseline, 52 and 78 weeks;Change from baseline to 52 and 78 weeks in HOMA2-%S and HOMA2%BTimepoint: Baseline, 52 and 78 weeks;Change in baseline to 26, 52 and 78 weeks on pulse rateTimepoint: Baseline, 26, 52 and 78 weeks;Incidence of LY2189265 antibodies at 26, 52, 78 weeks and 4 weeks after last dose of study drug, so 83 weeks at the maximumTimepoint: Baseline, 26, 52, 78 and 83 weeks;Incidence of treatment emergent adverse events at 26, 52 and 78 weeksTimepoint: 26, 52 and 78 weeks;Number of events of pancreatitis at 26, 52 and 78 weeksTimepoint: 26, 52 and 78 weeks;Number of patients achieving HbA1c l | — |
Countries
India
Contacts
Public ContactAnil Seth
Eli Lilly and Company
Outcome results
None listed