A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID: NCT02152371
Run by: Eli Lilly and Company
People needed: 300
Starts: 2014-05-01
Expected to finish: 2015-10-01
Last updated by the study team: 2019-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Valley Endocrine, Fresno — Fresno, California, United States
Mills-Peninsula Diabetes Research Insitute — San Mateo, California, United States
University Clinical Investigators, Inc. — Tustin, California, United States
Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
Northwest Endo Diabetes Research, LLC — Arlington Heights, Illinois, United States
Cotton O'Neil Clinic — Topeka, Kansas, United States
Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
AB Clinical Trials — Las Vegas, Nevada, United States
SHS Clinical Research Group — Toms River, New Jersey, United States
Bland Clinic, PA — Greensboro, North Carolina, United States
PMG Research of Knoxville — Knoxville, Tennessee, United States
Rainier Clinical Research Center — Renton, Washington, United States
Polyclinic — Seattle, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Beroun, Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Brandys Nad Labem-Stara Bolesl, Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — České Budějovice, Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Krnov, Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Prague, Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Budapest, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Debrecen, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Nagykanizsa, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Monza, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Olbia, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Pisa, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Rome, Italy

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