A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

NCT02973100 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 16568H9X-MC-GBGJ2016-002494-34
• Study Type: interventional
• Target: 318
• Locations: 6 countries
• Sites: 66

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment\*time as fixed effects.

  Baseline, Week 18

Secondary Outcomes (7)

• Percentage of Participants With HbA1c of <7.0%

  Week 18

• Change From Baseline in Fasting Serum Glucose (FSG)

  Baseline, Week 18

• Change From Baseline in Body Weight

  Baseline, Week 18

• Percentage of Participants Discontinuing Study Drug Due to Adverse Events

  Baseline through Week 18

• Rate of Documented Symptomatic Hypoglycemia

  Week 18

Study Arms (4)

Dulaglutide 4.5mg

EXPERIMENTAL

4.5mg of Dulaglutide administered subcutaneously (SC)

Drug: Dulaglutide

Dulaglutide 3.0mg

EXPERIMENTAL

3.0mg of Dulaglutide administered SC

Drug: Dulaglutide

Dulaglutide 1.5mg

ACTIVE COMPARATOR

1.5mg of Dulaglutide administered SC

Drug: Dulaglutide

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

Dulaglutide 1.5mg; Dulaglutide 3.0mg; Dulaglutide 4.5mg

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

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

You may qualify if:

• Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
• Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
• Have been treated with stable doses of metformin for at least 3 months
• Have a body mass index (BMI) ≥25 kilograms per square meter

You may not qualify if:

• Have type 1 diabetes (T1D)
• Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
• Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
• Have had chronic or acute pancreatitis any time prior to study entry
• Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
• Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (66)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206-4140, United States

Location

Marin Endocrine Associates

Greenbrae, California, 94904, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Encompass Clinical Research

Spring Valley Lake, California, 91978, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Infosphere

Van Nuys, California, 91405, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Axes Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

East Coast Institute For Research

Jacksonville, Florida, 32204, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Suncoast Research Group, LLC

Miami Lakes, Florida, 33135, United States

Location

Palm Harbor Medical Associates

Palm Harbor, Florida, 34684, United States

Location

In-Quest Medical Research, LLC - Norcross

Norcross, Georgia, 30071, United States

Location

East West Medical Institute

Honolulu, Hawaii, 96814, United States

Location

Elite Cilnical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

HSHS Medical Group Diabetes Research

Springfield, Illinois, 62711, United States

Location

American Health Network

Indianapolis, Indiana, 46254, United States

Location

Iderc, P.L.C.

Des Moines, Iowa, 50314, United States

Location

Cotton O'Neil Diabetes and Endocrinology Center

Topeka, Kansas, 66606, United States

Location

ActivMed Practices & Research, Inc

Methuen, Massachusetts, 01844, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

Manhattan Medical Research

New York Mills, New York, 10016, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

The Corvallis Clinic P.C.

Corvallis, Oregon, 97330, United States

Location

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, 15009, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Dallas Diabetes Endocrine Center

Dallas, Texas, 75230, United States

Location

Consano Clinical Research

San Antonio, Texas, 78231, United States

Location

Clinpoint Trial, LLC

Waxahachie, Texas, 75165, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, 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.

Brandýs nad Labem-Stará Boleslav, 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.

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, 11000, 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.

Prague, 181 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.

Praha 4 - Krc, 140 59, 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.

Chihuahua City, 31217, Mexico

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.

Cuernavaca, 62250, Mexico

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.

Guadalajara, 04460, Mexico

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.

Monterrey, 64460, Mexico

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.

Tampico, 89000, Mexico

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.

Bialystok, 15-404, Poland

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.

Bialystok, 15-445, Poland

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.

Gdansk, 80-546, Poland

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.

Lodz, 90-242, Poland

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.

Lublin, 20-333, Poland

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.

Lublin, 20-538, Poland

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.

Poznan, 61-655, Poland

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.

Poznan, 61-853, Poland

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.

Ruda Śląska, 41-709, Poland

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.

Szczecin, 70-506, Poland

Location

Marginal Doctor's Center

Manatí, 00674, Puerto Rico

Location

American Telemedicine Center

San Juan, 00917, 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.

Alba Iulia, 510053, Romania

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.

Baia Mare, 430222, Romania

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.

Iași, 700547, Romania

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.

Oradea, 410159, Romania

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.

Satu Mare, 440055, Romania

Location

Related Links

• A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: December 1, 2016
• Primary Completion: July 15, 2017
• Study Completion: August 14, 2017
• Last Updated: September 23, 2019
• Results First Posted: August 24, 2018

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

ME (5); RO (5); CZ (6); PR (2); PL (10); US (38)