A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Tirzepatide
- Conditions
- Type 2 Diabetes
- Sponsor
- Eli Lilly and Company
- Enrollment
- 282
- Locations
- 36
- Primary Endpoint
- Change From Baseline in HbA1c
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have type 2 diabetes
- •Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
- •Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
- •No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
- •Have had stable body weight (±5%) during the 90 days preceding screening
- •Have BMI ≥25 kilogram/square meter (kg/m²)
Exclusion Criteria
- •Have type 1 diabetes
- •Have a history of chronic or acute pancreatitis
- •Have a history of
- •proliferative diabetic retinopathy, or
- •diabetic maculopathy, or
- •nonproliferative diabetic retinopathy that requires acute treatment.
- •Have any of these cardiovascular (CV) conditions within 60 days prior to screening:
- •acute myocardial infarction,
- •cerebrovascular accident (stroke), or
- •hospitalization due to congestive heart failure (CHF).
Arms & Interventions
15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)
Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.
Intervention: Tirzepatide
4.5 mg Dulaglutide or MTD
Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Intervention: Dulaglutide
Outcomes
Primary Outcomes
Change From Baseline in HbA1c
Time Frame: Baseline, Week 40
HbA1c is the glycated 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 = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Secondary Outcomes
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants Who Achieved HbA1c <7%(Week 40)
- Percentage of Participants Who Achieved HbA1c <=6.5%(Week 40)
- Percentage of Participants Who Achieved HbA1c <5.7%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%(Week 40)
- Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)(Week 40)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 40)
- Change From Baseline in Waist Circumference(Baseline, Week 40)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 40)
- Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score(Baseline, Week 40)