A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes
Overview
- Phase
- Phase 3
- Intervention
- Tirzepatide
- Conditions
- Type 2 Diabetes
- Sponsor
- Eli Lilly and Company
- Enrollment
- 206
- Locations
- 28
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants 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) despite diet and exercise treatment
- •Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
- •Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
Exclusion Criteria
- •Have Type 1 Diabetes
- •Have a history of chronic or acute pancreatitis any time prior to study entry
- •Are currently receiving treatment for diabetic retinopathy and/or macular edema
- •Have a history of ketoacidosis or hyperosmolar state/coma
- •Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
- •Have acute or chronic hepatitis including a history of autoimmune hepatitis
- •Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
Arms & Interventions
5 Milligram (mg) Tirzepatide
Participants received 5 mg of 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 until the maintenance dose of 5 mg was reached.
Intervention: Tirzepatide
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP 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) until the maintenance dose of 10 mg was reached.
Intervention: Tirzepatide
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP 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 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Intervention: Tirzepatide
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
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 ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Secondary Outcomes
- Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])(Week 40)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)(Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)(Week 40)
- Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥5%(Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥10%(Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥15%(Week 40)