Phase 3
Completed N=2,002
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Source: ClinicalTrials.gov NCT03730662 ↗Enrolled (actual)
2,002
Serious AEs
16.8%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) — -2.43; -2.58; -1.44 Percentage of HbA1c — p=<0.001
◆ Published Evidence
Highly cited
332citations · ~83 / year
Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
Summary
The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.
Linked Publications (5)
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Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
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Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial.
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Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme.
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Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics.
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Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) |
-2.43; -2.58; -1.44 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c (5 mg) |
-2.24; -1.44 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-7.1; -9.5; -11.7; 1.9 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c of <7.0% |
80.98; 88.16; 90.72; 50.72 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-50.4; -54.9; -59.3; -51.4 | 0.672 |
| SECONDARY Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-58.4; -61.1; -66.1; -46.1 | — |
| SECONDARY Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide |
81800; 165000; 246000 | — |
| SECONDARY Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia |
0.10; 0.09; 0.11; 0.35 | — |
Eligibility Criteria
Inclusion Criteria
Participants must:
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.5% and ≤10.5%
- Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
- Have increased risk for cardiovascular (CV) events
- Be of stable weight (± 5%)
- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria
Participants must not:
- 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 immediate or urgent treatment
- Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
- 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 2
- Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
- Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Data sourced from ClinicalTrials.gov (NCT03730662) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.