A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Overview
- Phase
- Phase 3
- Intervention
- Tirzepatide
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Eli Lilly and Company
- Enrollment
- 478
- Locations
- 50
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have been diagnosed with type 2 diabetes mellitus (T2DM).
- •Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
- •Have HbA1c between ≥7.0% and ≤9.5%.
- •Be of stable weight (± 5%) for at least 3 months before screening.
- •Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.
Exclusion Criteria
- •Have type 1 diabetes mellitus.
- •Have had chronic or acute pancreatitis any time prior to study entry.
- •Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
- •Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
- •Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m².
- •Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type
- •Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Arms & Interventions
5 mg Tirzepatide
Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
Intervention: Tirzepatide
10 mg Tirzepatide
Participants received 10mg of tirzepatide as subcutaneous injection once a week.
Intervention: Tirzepatide
15 mg Tirzepatide
Participants received 15mg of tirzepatide as subcutaneous injection once a week.
Intervention: Tirzepatide
Placebo
Participants received placebo as subcutaneous injection once a week.
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 determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Secondary Outcomes
- Percentage of Participants With HbA1c Target Value of <5.7%(Week 40)
- Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 40)
- Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia(Baseline through end of safety follow-up (up to week 44))
- Percentage of Participants Who Achieved Weight Loss ≥5%(Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants With HbA1c Target Value of <7%(Week 40)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide(Week 7, 15 and 23)