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

NCT ID: NCT02152371

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dulaglutide + Insulin Glargine

1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered SQ

Insulin Glargine

Intervention Type: DRUG

Administered SQ

Metformin

Intervention Type: DRUG

Administered orally

Placebo + Insulin Glargine

Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SQ

Insulin Glargine

Intervention Type: DRUG

Administered SQ

Metformin

Intervention Type: DRUG

Administered orally

Interventions

Dulaglutide

Administered SQ

Intervention Type: DRUG

Placebo

Administered SQ

Intervention Type: DRUG

Insulin Glargine

Administered SQ

Intervention Type: DRUG

Metformin

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY2189265

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Centro de Endocrinologia y Nutricion del Turabo

Caguas, , Puerto Rico

Manati Center for Clinical Research Inc

Manatí, , Puerto Rico

Ponce School of Medicine CAIMED Center

Ponce, , Puerto Rico

Endocrine Lipid Diabetes Research Institute

Ponce, , Puerto Rico

GCM Medical Group PSC

San Juan, , Puerto Rico

American Telemedicine Center

San Juan, , Puerto Rico

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.

Alzira, , Spain

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.

Cadiz, , Spain

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.

Madrid, , Spain

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.

Seville, , Spain

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.

Teruel, , Spain

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.

Mortimer, Berks, United Kingdom

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.

Leicester, Leicestershire, United Kingdom

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.

Guildford, Surrey, United Kingdom

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.

Swansea, Wales, United Kingdom

Countries

United States; Czechia; Hungary; Italy; Puerto Rico; Spain; United Kingdom

References

Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.

Reference Type: DERIVED

PMID: 29430801 (View on PubMed)

Yu M, Brunt KV, Milicevic Z, Varnado O, Boye KS. Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9). Clin Ther. 2017 Nov;39(11):2284-2295. doi: 10.1016/j.clinthera.2017.10.002. Epub 2017 Oct 27.

Reference Type: DERIVED

PMID: 29110972 (View on PubMed)

Other Identifiers

H9X-MC-GBDI

Identifier Type: OTHER

Identifier Source: secondary_id

2012-004229-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13195

Identifier Type: -

Identifier Source: org_study_id