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Glucagon-like peptide-1 receptor agonist

Tirzepatide vs Dulaglutide for Type 2 Diabetes (SURPASS-CVOT Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of type 2 diabetes
Have confirmed atherosclerotic cardiovascular disease
Must not have
Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (approximate maximum 54 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new diabetes medication to see if it is more effective and safe than another existing diabetes medication.

Who is the study for?
This trial is for adults with type 2 diabetes who are overweight (BMI ≥25 kg/m²) and have a history of heart disease. They should have an HbA1c level between 7.0% to ≤10.5%. People with plans for certain eye treatments, gastric surgeries, or those with type 1 diabetes, recent severe blood loss, pancreatitis, or major cardiovascular events in the last two months cannot join.
What is being tested?
The study compares Tirzepatide (LY3298176) to Dulaglutide in reducing heart-related issues in people with type 2 diabetes at increased risk of cardiovascular events. It aims to see which drug is more effective and safe.
What are the potential side effects?
Possible side effects may include digestive problems like nausea or vomiting, low blood sugar levels (hypoglycemia), allergic reactions at the injection site, and potential thyroid tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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I have been diagnosed with heart disease caused by hardened arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a known issue with my stomach emptying or have had/planning stomach surgery.
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I or my family have a history of MTC or MEN-2.
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I have been in remission for less than 5 years or have an active cancer.
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I have not had a blood transfusion or severe blood loss in the last 3 months.
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I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.
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I have had pancreatitis before.
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I have had severe low blood sugar or didn't notice it happening in the last 6 months.
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I have had ketoacidosis or a severe hyperglycemic state before.
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I am planning treatment for eye conditions related to diabetes.
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I have type 1 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (approximate maximum 54 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (approximate maximum 54 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Secondary study objectives
Change from Baseline in Blood Lipids
Change from Baseline in Body Weight
Change from Baseline in Hemoglobin A1c (HbA1c)
+12 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Tirzepatide administered subcutaneously (SC) once a week.
Group II: DulaglutideActive Control1 Intervention
Dulaglutide administered SC once a week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,667 Previous Clinical Trials
3,215,178 Total Patients Enrolled
11 Trials studying Diabetes
15,619 Patients Enrolled for Diabetes
Study DirectorEli Lilly and Company
1,383 Previous Clinical Trials
412,842 Total Patients Enrolled
3 Trials studying Diabetes
4,328 Patients Enrolled for Diabetes

Media Library

Dulaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04255433 — Phase 3
Diabetes Research Study Groups: Tirzepatide, Dulaglutide
Diabetes Clinical Trial 2023: Dulaglutide Highlights & Side Effects. Trial Name: NCT04255433 — Phase 3
Dulaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255433 — Phase 3
Diabetes Patient Testimony for trial: Trial Name: NCT04255433 — Phase 3
~1330 spots leftby Jun 2025
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