A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Who is this study for? Patients with Type 2 Diabetes
Status: Completed
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have Type 2 Diabetes (T2D)
• Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.
Locations
United States
Alabama
Syed Research Consultants Llc
Sheffield
California
San Fernando Valley Health Institute
Canoga Park
Valley Endocrine, Fresno
Fresno
National Research Institute - Huntington Park
Huntington Park
Catalina Research Institute, LLC
Montclair
National Research Institute - Panorama City
Panorama City
Anderson Clinical Research
Redlands
Artemis Institute for Clinical Research
Riverside
Artemis Institute for Clinical Research
San Diego
National Research Institute (NRI) - Santa Ana
Santa Ana
Diablo Clinical Research, Inc.
Walnut Creek
Florida
South Florida Clinical Research Institute
Margate
ForCare Clinical Research
Tampa
Encore Medical Research - Weston
Weston
Iowa
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Idaho
Elite Clinical Trials
Blackfoot
Humphreys Diabetes Center
Boise
Rocky Mountain Clinical Research
Idaho Falls
Elite Clinical Trials
Rexburg
Kansas
Cotton O'Neil Clinic
Topeka
Maryland
Centennial Medical Group
Elkridge
Missouri
Clinvest Research LLC
Springfield
Mississippi
MediSync Clinical Research
Petal
Montana
Logan Health Research
Kalispell
North Dakota
Lillestol Research
Fargo
Oklahoma
Intend Research, LLC
Norman
Pennsylvania
Heritage Valley Medical Group, Inc.
Beaver
Preferred Primary Care Physicians
Pittsburgh
Frontier Clinical Research, LLC
Smithfield
Preferred Primary Care Physicians
Uniontown
South Carolina
The Research Center of The Upstate
Greenville
Texas
Dallas Diabetes Research Center
Dallas
Diabetes and Thyroid Center of Fort Worth
Fort Worth
Endocrine Ips, Pllc
Houston
Laila A Hassan, MD, PA
Houston
Southern Endocrinology Associates
Mesquite
North Hills Family Medicine/North Hills Medical Research
North Richland Hills
Washington
Rainier Clinical Research Center
Renton
Universal Research Group
Tacoma
The Vancouver Clinic
Vancouver
Other Locations
Puerto Rico
Advanced Clinical Research, LLC
Bayamon
Manati Center for Clinical Research
Manati
Latin Clinical Trial Center
San Juan
Time Frame
Start Date: 2021-05-13
Completion Date: 2022-10-27
Participants
Target number of participants: 281
Treatments
Experimental: 0.5 milligrams (mg) LY3437943
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
Experimental: 4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Experimental: 4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
Experimental: 8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Experimental: 8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
Experimental: 12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
Active_comparator: 1.5 mg Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Placebo_comparator: Placebo
Participants received placebo administered as SC injection QW.
Authors
Joseph M Labuda II, Rambod Rouhbakhsh, Tanya R Bogle, Sandro Bacchelli, Juan Loy, Angel Luis Comulada-Rivera, Robert Allen Jenders, Sabrina Benjamin, Lisa Connery, Stacey Layle, Bryce A. Palchick, Stanley H. Hsia, Helen L Stacey, John Gabriel, Alan Glenn Wynne, Leslie J Klaff, David Gregory True, Gary W Soucie, Michael J Oliver, Harlicia Farley, Sherwin D'Souza, Rizwana H Mohseni, Frank D Wade, Carl D Vance, Mark T. Leibowitz, Ramon Ortiz-Carrasquillo, John Charles Parker, Carl Roger Meisner, Julio Rosenstock, Sumana Gangi, Anjanette Tan, Anuj Bhargava, Paul Carlton Norwood, Alex Gonzalez-Bossolo, Aaron Karr, Stacey Condren, Michael J Lillestol, Sarah Lavery
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company