A Study of LY3437943 in Participants With Type 2 Diabetes
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3437943 Maintenance Dose 1 LY3437943 administered by subcutaneous (SC) injection |
Drug: LY3437943
Administered SC
|
Experimental: LY3437943 Maintenance Dose 2 LY3437943 administered by SC injection |
Drug: LY3437943
Administered SC
|
Experimental: LY3437943 Maintenance Dose 3 LY3437943 administered by SC injection |
Drug: LY3437943
Administered SC
|
Experimental: LY3437943 Dose 4 LY3437943 administered by SC injection |
Drug: LY3437943
Administered SC
|
Active Comparator: Dulaglutide Dulaglutide will be given SC |
Drug: Dulaglutide
Administered SC
|
Placebo Comparator: Placebo Placebo will be given SC |
Drug: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, 24 Weeks]
Change in HbA1c (%) from baseline in LY3437943 relative to placebo
Secondary Outcome Measures
- Change from Baseline in HbA1c [Baseline, 24 Weeks]
Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide
- Change from Baseline in HbA1c [Baseline, 36 Weeks]
Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide
- Percentage of Participant Reaching HbA1c <7.0% [Week 24]
Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide
- Percentage of Participant Reaching HbA1c <7.0% [Week 36]
Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide
- Change from Baseline in Fasting Blood Glucose (FBG) [Baseline, 24 Weeks]
Change in FBG in LY3437943 relative to placebo and dulaglutide
- Change from Baseline in Fasting Blood Glucose (FBG) [Baseline, 36 Weeks]
Change in FBG in LY3437943 relative to placebo and dulaglutide
- Change from Baseline in Body Weight [Baseline, 24 Weeks]
Change in body weight in LY3437943 relative to placebo and dulaglutide
- Change from Baseline in Body Weight [Baseline, 36 Weeks]
Change in body weight in LY3437943 relative to placebo and dulaglutide
- Pharmacokinetics (PK) Plasma concentration of LY3437943 [Predose: Week 0, 1, 4, 12, 24, 30, 36 Postdose: Week 2, 8, 16, 20]
Plasma concentration of LY3437943 will be assessed
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Syed Research Consultants Llc | Sheffield | Alabama | United States | 35660 |
2 | San Fernando Valley Health Institute | Canoga Park | California | United States | 91304 |
3 | Valley Endocrine, Fresno | Fresno | California | United States | 93720 |
4 | National Research Institute - Huntington Park | Huntington Park | California | United States | 90255 |
5 | Catalina Research Institute, LLC | Montclair | California | United States | 91763 |
6 | National Research Institute - Panorama City | Panorama City | California | United States | 91402 |
7 | Anderson Clinical Research | Redlands | California | United States | 92374 |
8 | Artemis Institute for Clinical Research | Riverside | California | United States | 92503 |
9 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
10 | National Research Institute (NRI) - Santa Ana | Santa Ana | California | United States | 92704 |
11 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
12 | South Florida Clinical Research Institute | Margate | Florida | United States | 33063 |
13 | ForCare Clinical Research | Tampa | Florida | United States | 33613 |
14 | Encore Medical Research - Weston | Weston | Florida | United States | 33331 |
15 | Elite Clinical Trials | Blackfoot | Idaho | United States | 83221 |
16 | Humphreys Diabetes Center | Boise | Idaho | United States | 83702 |
17 | Rocky Mountain Clinical Research | Idaho Falls | Idaho | United States | 83404 |
18 | Elite Clinical Trials | Rexburg | Idaho | United States | 83440 |
19 | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | United States | 50265 |
20 | Cotton O'Neil Clinic | Topeka | Kansas | United States | 66606 |
21 | Centennial Medical Group | Elkridge | Maryland | United States | 21075 |
22 | MediSync Clinical Research | Petal | Mississippi | United States | 39465 |
23 | Clinvest Research LLC | Springfield | Missouri | United States | 65810 |
24 | Logan Health Research | Kalispell | Montana | United States | 59901 |
25 | Lillestol Research | Fargo | North Dakota | United States | 58104 |
26 | Intend Research, LLC | Norman | Oklahoma | United States | 73069 |
27 | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | United States | 15009 |
28 | Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | United States | 15236 |
29 | Frontier Clinical Research, LLC | Smithfield | Pennsylvania | United States | 15478 |
30 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
31 | The Research Center of The Upstate | Greenville | South Carolina | United States | 29607 |
32 | Dallas Diabetes Research Center | Dallas | Texas | United States | 75230 |
33 | Diabetes and Thyroid Center of Fort Worth | Fort Worth | Texas | United States | 76132 |
34 | Endocrine Ips, Pllc | Houston | Texas | United States | 77079 |
35 | Laila A Hassan, MD, PA | Houston | Texas | United States | 77089 |
36 | Southern Endocrinology Associates | Mesquite | Texas | United States | 75149 |
37 | North Hills Family Medicine/North Hills Medical Research | North Richland Hills | Texas | United States | 76180 |
38 | Rainier Clinical Research Center | Renton | Washington | United States | 98057 |
39 | Universal Research Group | Tacoma | Washington | United States | 98405 |
40 | The Vancouver Clinic | Vancouver | Washington | United States | 98664 |
41 | Advanced Clinical Research, LLC | Bayamon | Puerto Rico | 00961 | |
42 | Manati Center for Clinical Research | Manati | Puerto Rico | 674 | |
43 | Latin Clinical Trial Center | San Juan | Puerto Rico | 909 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17774
- J1I-MC-GZBD