A Study of LY3437943 in Participants With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867785
• Other study ID #: 17774
• Secondary ID: J1I-MC-GZBD
• Status: Completed
• Phase: Phase 2
• Start date: May 13, 2021
• Est. completion date: October 27, 2022

Study information

• Verified date: June 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: October 27, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Have type 1 diabetes mellitus (T1DM)

• Have ketoacidosis

• Have retinopathy, maculopathy

• Have history of pancreatitis

• Have obesity induced by other endocrine disorders

• Have uncontrolled hypertension

• Have acute or chronic hepatitis

• Have chronic kidney disease

• Have an autoimmune abnormality for example, lupus or rheumatoid arthritis

• Have an active or untreated malignancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• LY3437943
Administered SC
• Dulaglutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Manati Center for Clinical Research	Manati
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Humphreys Diabetes Center	Boise	Idaho
United States	San Fernando Valley Health Institute	Canoga Park	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Centennial Medical Group	Elkridge	Maryland
United States	Lillestol Research	Fargo	North Dakota
United States	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas
United States	Valley Endocrine, Fresno	Fresno	California
United States	The Research Center of The Upstate	Greenville	South Carolina
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Laila A Hassan, MD, PA	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Logan Health Research	Kalispell	Montana
United States	South Florida Clinical Research Institute	Margate	Florida
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Catalina Research Institute, LLC	Montclair	California
United States	Intend Research, LLC	Norman	Oklahoma
United States	North Hills Family Medicine/North Hills Medical Research	North Richland Hills	Texas
United States	National Research Institute - Panorama City	Panorama City	California
United States	MediSync Clinical Research	Petal	Mississippi
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Anderson Clinical Research	Redlands	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Elite Clinical Trials	Rexburg	Idaho
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	National Research Institute (NRI) - Santa Ana	Santa Ana	California
United States	Syed Research Consultants Llc	Sheffield	Alabama
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Clinvest Research LLC	Springfield	Missouri
United States	Universal Research Group	Tacoma	Washington
United States	ForCare Clinical Research	Tampa	Florida
United States	Cotton O'Neil Clinic	Topeka	Kansas
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	The Vancouver Clinic	Vancouver	Washington
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Encore Medical Research - Weston	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c)	Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.	Baseline, 24 Weeks
Secondary	Change From Baseline in HbA1c	Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.	Baseline, 24 Weeks
Secondary	Change From Baseline in HbA1c	Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline Body Mass Index (BMI) Group (<30 kilograms/square meter (kg/m2), >=30 kg/m2)*Time + Baseline*Time.	Baseline, 36 Weeks
Secondary	Percentage of Participants Reaching HbA1c <7.0%	Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, =30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate.	Week 24
Secondary	Percentage of Participant Reaching HbA1c <7.0%	Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, =30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate.	Week 36
Secondary	Change From Baseline in Fasting Blood Glucose (FBG)	Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.	Baseline, 24 Weeks
Secondary	Change From Baseline in Fasting Blood Glucose (FBG)	Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time.	Baseline, 36 Weeks
Secondary	Change From Baseline in Body Weight	Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.	Baseline, 24 Weeks
Secondary	Change From Baseline in Body Weight	Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time.	Baseline, 36 Weeks
Secondary	Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943	The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.	Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

External Links

•   A Study of LY3437943 in Participants With Type 2 Diabetes