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A Study of LY3437943 in Participants With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3437943
Dulaglutide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Syed Research Consultants Llc
  • San Fernando Valley Health Institute
  • Valley Endocrine, Fresno
  • National Research Institute - Huntington Park
  • Catalina Research Institute, LLC
  • National Research Institute - Panorama City
  • Anderson Clinical Research
  • Artemis Institute for Clinical Research
  • Artemis Institute for Clinical Research
  • National Research Institute (NRI) - Santa Ana
  • Diablo Clinical Research, Inc.
  • South Florida Clinical Research Institute
  • ForCare Clinical Research
  • Encore Medical Research - Weston
  • Elite Clinical Trials
  • Humphreys Diabetes Center
  • Rocky Mountain Clinical Research
  • Elite Clinical Trials
  • Iowa Diabetes and Endocrinology Research Center
  • Cotton O'Neil Clinic
  • Centennial Medical Group
  • MediSync Clinical Research
  • Clinvest Research LLC
  • Logan Health Research
  • Lillestol Research
  • Intend Research, LLC
  • Heritage Valley Medical Group, Inc.
  • Preferred Primary Care Physicians
  • Frontier Clinical Research, LLC
  • Preferred Primary Care Physicians
  • The Research Center of The Upstate
  • Dallas Diabetes Research Center
  • Diabetes and Thyroid Center of Fort Worth
  • Endocrine Ips, Pllc
  • Laila A Hassan, MD, PA
  • Southern Endocrinology Associates
  • North Hills Family Medicine/North Hills Medical Research
  • Rainier Clinical Research Center
  • Universal Research Group
  • The Vancouver Clinic
  • Advanced Clinical Research, LLC
  • Manati Center for Clinical Research
  • Latin Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

0.5 milligrams (mg) LY3437943

4 mg LY3437943 (2 mg)

4 mg LY3437943 (4 mg)

8 mg LY3437943 (2 mg)

8 mg LY3437943 (4 mg)

12 mg LY3437943 (2 mg)

1.5 mg Dulaglutide

Placebo

Arm Description

Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.

Participants received 4 mg LY3437943 administered as SC injection QW.

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.

Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.

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.

Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.

Participants received placebo administered as SC injection QW.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 29, 2021
Last Updated
June 8, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04867785
Brief Title
A Study of LY3437943 in Participants With Type 2 Diabetes
Official Title
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 milligrams (mg) LY3437943
Arm Type
Experimental
Arm Description
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
Arm Title
4 mg LY3437943 (2 mg)
Arm Type
Experimental
Arm Description
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Arm Title
4 mg LY3437943 (4 mg)
Arm Type
Experimental
Arm Description
Participants received 4 mg LY3437943 administered as SC injection QW.
Arm Title
8 mg LY3437943 (2 mg)
Arm Type
Experimental
Arm Description
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Arm Title
8 mg LY3437943 (4 mg)
Arm Type
Experimental
Arm Description
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
Arm Title
12 mg LY3437943 (2 mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
1.5 mg Dulaglutide
Arm Type
Active Comparator
Arm Description
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo administered as SC injection QW.
Intervention Type
Drug
Intervention Name(s)
LY3437943
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Description
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.
Time Frame
Baseline, 24 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline in HbA1c
Description
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.
Time Frame
Baseline, 36 Weeks
Title
Percentage of Participants Reaching HbA1c <7.0%
Description
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.
Time Frame
Week 24
Title
Percentage of Participant Reaching HbA1c <7.0%
Description
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.
Time Frame
Week 36
Title
Change From Baseline in Fasting Blood Glucose (FBG)
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline in Fasting Blood Glucose (FBG)
Description
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.
Time Frame
Baseline, 36 Weeks
Title
Change From Baseline in Body Weight
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline in Body Weight
Description
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.
Time Frame
Baseline, 36 Weeks
Title
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
Description
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Time Frame
Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Syed Research Consultants Llc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
San Fernando Valley Health Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Valley Endocrine, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
National Research Institute - Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
National Research Institute (NRI) - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
South Florida Clinical Research Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Encore Medical Research - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Humphreys Diabetes Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Elite Clinical Trials
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
MediSync Clinical Research
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Logan Health Research
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
The Research Center of The Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Thyroid Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Laila A Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
North Hills Family Medicine/North Hills Medical Research
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Universal Research Group
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
The Vancouver Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Advanced Clinical Research, LLC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Manati Center for Clinical Research
City
Manati
ZIP/Postal Code
674
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
909
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6tv02tRhvMamBP866x6OPm
Description
A Study of LY3437943 in Participants With Type 2 Diabetes

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A Study of LY3437943 in Participants With Type 2 Diabetes

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