A Study of LY3437943 in Participants With Type 2 Diabetes
- Registration Number
- NCT04867785
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.5 milligrams (mg) LY3437943 LY3437943 Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW). 4 mg LY3437943 (2 mg) LY3437943 Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. 4 mg LY3437943 (4 mg) LY3437943 Participants received 4 mg LY3437943 administered as SC injection QW. 8 mg LY3437943 (2 mg) LY3437943 Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. 12 mg LY3437943 (2 mg) LY3437943 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. Placebo Placebo Participants received placebo administered as SC injection QW. 8 mg LY3437943 (4 mg) LY3437943 Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW. 1.5 mg Dulaglutide Dulaglutide Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, 24 Weeks 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
Name Time Method Change From Baseline in Body Weight Baseline, 36 Weeks 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.
Percentage of Participant Reaching HbA1c <7.0% Week 36 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) Baseline, 36 Weeks 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 HbA1c Baseline, 36 Weeks 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% Week 24 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.
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943 Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36 The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Trial Locations
- Locations (40)
Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States
San Fernando Valley Health Institute
🇺🇸Canoga Park, California, United States
Valley Endocrine, Fresno
🇺🇸Fresno, California, United States
National Research Institute - Huntington Park
🇺🇸Huntington Park, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
National Research Institute - Panorama City
🇺🇸Panorama City, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
National Research Institute (NRI) - Santa Ana
🇺🇸Santa Ana, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Scroll for more (30 remaining)Syed Research Consultants Llc🇺🇸Sheffield, Alabama, United States