A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
3 other identifiers
interventional
420
6 countries
51
Brief Summary
The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Apr 2014
Typical duration for phase_2 diabetes-mellitus-type-2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
April 14, 2021
CompletedMay 27, 2021
May 1, 2021
1.3 years
April 17, 2014
March 19, 2021
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Baseline, Week 12
Secondary Outcomes (14)
Change From Baseline in HbA1c at Week 24
Baseline, Week 24
Percent Change From Baseline in Body Weight
Baseline, Week 12; Baseline, Week 24
Change From Baseline in Fasting Blood Glucose
Baseline, Week 12; Baseline, Week 24
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week (Wk) 12; Baseline, Week 24
Change From Baseline in Lipids
Baseline, Week 24
- +9 more secondary outcomes
Study Arms (6)
10 mg LY2944876
EXPERIMENTAL10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
15 mg LY2944876
EXPERIMENTAL15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
30 mg LY2944876
EXPERIMENTAL30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
50 mg LY2944876
EXPERIMENTAL50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Exenatide extended-release
EXPERIMENTAL2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Placebo
PLACEBO COMPARATORPlacebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Interventions
Oral
Eligibility Criteria
You may qualify if:
- Men or women with diabetes mellitus Type 2
- Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
- Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening
You may not qualify if:
- Women of child bearing potential
- Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
- Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
- Participants with impaired renal function (serum creatinine \>124 micromole per liter (µmol/L) \[1.4 milligrams per deciliter (mg/dL)\] in women, \>133 µmol/L \[1.5 mg/dL\] in men)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
National Research Institute
Los Angeles, California, 90057, United States
Desert Medical Group Inc
Palm Springs, California, 92262, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Meridien Research
Bradenton, Florida, 34208, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Compass Research
Oviedo, Florida, 32765, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Iderc, P.L.C.
Des Moines, Iowa, 50314, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
St John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Mercy Health Research
Washington, Missouri, 63090, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063, United States
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
San Gabriel Clinical Research
Georgetown, Texas, 78626, United States
Oakwell Clinical Research
San Antonio, Texas, 78218, United States
Southwest Health Associates, P.A.
Sugar Land, Texas, 77478, United States
Wade Family Medicine
Bountiful, Utah, 84010, 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.
Ampelokipoi, 11527, Greece
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.
Athens, 11527, Greece
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Thessaloniki, 57010, Greece
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Chihuahua City, 31238, Mexico
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Guadalajara, 44690, Mexico
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Tampico, 89000, Mexico
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Bialystok, 15-351, Poland
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Gdansk, 80-546, Poland
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Gdynia, 81-553, Poland
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Lodz, 90-242, Poland
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
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
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.
Warsaw, 01-518, Poland
Manati Medical Center
Manatí, 00674, Puerto Rico
American Telemedicine Center
San Juan, 00917-3104, 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.
Cluj-Napoca, 400349, Romania
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
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.
Ploieşti, 100342, Romania
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.
Târgu Mureş, 540098, Romania
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.
Timișoara, 300456, Romania
Related Publications (1)
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PMID: 30957581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
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
April 17, 2014
First Posted
April 22, 2014
Study Start
April 1, 2014
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
May 27, 2021
Results First Posted
April 14, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.