Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Overview
- Phase
- Phase 3
- Intervention
- Tirzepatide
- Conditions
- Type 2 Diabetes
- Sponsor
- Eli Lilly and Company
- Enrollment
- 475
- Locations
- 47
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
- •Have HbA1c between ≥7.0% and ≤10.5%.
- •Have a stable weight (± 5%) for at least 3 months before screening.
- •Have a body mass index (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 \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
- •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
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Intervention: Tirzepatide
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Intervention: Tirzepatide
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Intervention: Tirzepatide
Placebo
Placebo administered SC once a week.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Secondary Outcomes
- Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 40)
- Percentage of Participants Achieving an HbA1c Target Value of <5.7%(Week 40)
- Change From Baseline in HbA1c (5 mg)(Baseline, Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss ≥5%(Week 40)
- Percentage Change From Baseline in Daily Mean Insulin Glargine Dose(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 Safety Follow-Up (Up to Week 44))
- Percentage of Participants Achieving an HbA1c Target Value of <7%(Week 40)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide(Week 7, 15, 23 and 39 post dose)