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

NCT02152371 | Completed Phase 3 Results

• 3 other identifiers: 13195H9X-MC-GBDI2012-004229-25
• Study Type: interventional
• Target: 300
• Locations: 7 countries
• Sites: 40

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)

  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.

  Baseline, 28 Weeks

Secondary Outcomes (15)

• Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)

  Baseline, 28 Weeks

• Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)

  Baseline, 28 Weeks

• Change From Baseline to 28 Weeks in Body Weight

  Baseline, 28 Weeks

• Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose

  Baseline, 28 Weeks

• Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events

  Baseline through 28 Weeks

Study Arms (2)

Dulaglutide + Insulin Glargine

EXPERIMENTAL

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.

Drug: Dulaglutide; Drug: Insulin Glargine; Drug: Metformin

Placebo + Insulin Glargine

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Insulin Glargine; Drug: Metformin

Interventions

Dulaglutide DRUG

Administered SQ

Also known as: LY2189265

Dulaglutide + Insulin Glargine

Placebo DRUG

Administered SQ

Placebo + Insulin Glargine

Insulin Glargine DRUG

Administered SQ

Dulaglutide + Insulin Glargine; Placebo + Insulin Glargine

Metformin DRUG

Administered orally

Dulaglutide + Insulin Glargine; Placebo + Insulin Glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (40)

Valley Endocrine, Fresno

Fresno, California, 93720, United States

Location

Mills-Peninsula Diabetes Research Insitute

San Mateo, California, 94401, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Northwest Endo Diabetes Research, LLC

Arlington Heights, Illinois, 60005, United States

Location

Cotton O'Neil Clinic

Topeka, Kansas, 66606, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

SHS Clinical Research Group

Toms River, New Jersey, 08753, United States

Location

Bland Clinic, PA

Greensboro, North Carolina, 27401, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37912, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Polyclinic

Seattle, Washington, 98104, United States

Location

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, 26601, Czechia

Location

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, 25001, Czechia

Location

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, 370 01, Czechia

Location

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, 79401, Czechia

Location

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, 149 00, Czechia

Location

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, 1139, Hungary

Location

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, 4043, Hungary

Location

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, 8800, Hungary

Location

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, 20900, Italy

Location

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, 07026, Italy

Location

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, 56126, Italy

Location

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, 00128, Italy

Location

Centro de Endocrinologia y Nutricion del Turabo

Caguas, 00726, Puerto Rico

Location

Manati Center for Clinical Research Inc

Manatí, 00674, Puerto Rico

Location

Ponce School of Medicine CAIMED Center

Ponce, 00716, Puerto Rico

Location

Endocrine Lipid Diabetes Research Institute

Ponce, 00717-2075, Puerto Rico

Location

GCM Medical Group PSC

San Juan, 00909, Puerto Rico

Location

American Telemedicine Center

San Juan, 00917-3104, Puerto Rico

Location

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, 46600, Spain

Location

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, 11540, Spain

Location

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, 28223, Spain

Location

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, 41010, Spain

Location

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, 44002, Spain

Location

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, RG7 3SQ, United Kingdom

Location

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, LE5 4PW, United Kingdom

Location

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, GU2 7XX, United Kingdom

Location

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, SA6 6NL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29430801 DERIVED

• 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.

  PMID: 29110972 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 25, 2019
• Results First Posted: December 7, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IT (4); CZ (5); ES (5); HU (3); GB (4); US (13); PR (6)