a study of dulaglutide (ly2189265) in participants with type ii diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type ii diabetes who are taking once-daily insulin glargine. the study will last about 31 weeks for each participant.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (based on the world health organization's \[who\] diagnostic criteria) * have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening * doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label * have an hba1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening * require further insulin glargine dose increase at week 3 per the treat-to-target (ttt) algorithm based on the smpg data collected during the prior week * have stable weight (±5%) ≥3 months prior to screening * have body mass index (bmi) ≤45 kilograms per square meter (kg/m\^2) at screening * are able and willing to administer once weekly randomized therapy * are females of childbearing potential who must: * test negative for pregnancy at screening, based on a serum pregnancy test * agree to use a reliable method of birth control * not be breastfeeding exclusion criteria: * have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3 * have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma * have a history of hypoglycemia unawareness within the 6 months prior to screening * have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3 * are receiving chronic (\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3 * have had any of the following cardiovascular conditions within the 2 months prior to screening: acute myocardial infarction (mi), new york heart association (nyha) class iii or class iv heart failure, or cerebrovascular accident (stroke) * have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory * have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening * have an estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73 square meter (ml/min/m\^2), calculated by the chronic kidney disease-epidemiology (ckd-epi) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum creatinine ≥1.5 mg/deciliter \[dl\] \[male\] or ≥1.4 mg/dl \[female\] or egfr \[ckd-epi\] \<60 ml/min/1.73 m\^2) * have evidence of a significant, uncontrolled endocrine abnormality * have any self or family history of type 2a or type 2b multiple endocrine neoplasia (men 2a or 2b) in the absence of known c-cell hyperplasia * have any self or family history of medullary c-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of men 2a or 2b syndrome) * have serum calcitonin ≥20 picograms/ml, as determined by the central laboratory * have evidence of a significant, active autoimmune abnormality * have any other condition not listed in this section that is a contraindication for use of insulin glargine, or, for participants using metformin, have a condition that is a contraindication for the use of metformin and would require metformin discontinuation per label * have a history of transplanted organ * have a history of active or untreated malignancy, or are in remission from a clinically significant malignancy during the 5 years prior to screening * have a history of any other condition which, in the opinion of the investigator, may preclude the participants from following and completing the protocol * have any hematologic condition that may interfere with hba1c measurement (eg, hemolytic anemias, sickle-cell disease)