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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (approximate maximum 54 months)
Awards & highlights

SURPASS-CVOT 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.Check my eligibility
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.See study design
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.

SURPASS-CVOT Trial Eligibility Criteria

Inclusion Criteria

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

SURPASS-CVOT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Secondary outcome measures
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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

SURPASS-CVOT 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
~7590

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,187,630 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
391,953 Total Patients Enrolled

Media Library

Dulaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04255433 — Phase 3
Type 2 Diabetes Research Study Groups: Tirzepatide, Dulaglutide
Type 2 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
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04255433 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any short or long-term dangers associated with taking Tirzepatide?

"This Tirzepatide study is classified as a Phase 3 trial, which means that while there is efficacy data available, the focus is on further confirming safety through multiple rounds of testing."

Answered by AI

How many study participants are needed for this clinical trial?

"This clinical trial is not recruiting patients at this moment. The last update to the study was on October 3rd, 2022. However, there are 1508 other trials related to type 2 diabetes mellitus and 19 for Tirzepatide that are actively looking for participants."

Answered by AI

Are there other scientific investigations that have studied Tirzepatide?

"Tirzepatide is being studied in 19 separate clinical trials, 9 of which are in Phase 3. The trial locations for Tirzepatide are primarily situated in Qinhuangdao, Hebei; but there are a total of 1597 active sites for these medical studies."

Answered by AI

How many total facilities are needed to manage this clinical trial?

"There are over 100 medical facilities enrolling patients in this clinical trial, including Cardiology Partners Clinical Research Institute, LLC in Wellington, Florida, L-MARC Research Center in Louisville, Kentucky, and Cardiovascular Associates of the Delaware Valley in Haddon Heights, New jersey."

Answered by AI

Why is Tirzepatide commonly prescribed?

"Tirzepatide is most often used to control blood sugar levels in patients with type 2 diabetes mellitus. Additionally, this medication can be prescribed to help manage cardiovascular risk factors, diet, and exercise."

Answered by AI

Are we still enrolling people for this experiment?

"Although this study is not actively recruiting at the moment, it's still possible to participate. The trial was initially posted on 5/29/2020 and was last edited on 10/3/2022. If you are seeking other studies, there are presently 1508 clinical trials actively recruiting participants with type 2 diabetes mellitus and 19 trials for Tirzepatide actively looking for patients."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
California
Tennessee
Other
How old are they?
65+
18 - 65
What site did they apply to?
Riverside County Regional Medical Center
Diabetes Associates Medical Group
PMG Research of Knoxville
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I really need the money. I want improved treatment. Tried couple things no success.
PatientReceived no prior treatments
Glucs vary widely. Get under control. to see how i can iprove my diabeties.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a paid trial? How long does screning take? What is the # of visits to be made to Knoxville and how often are the visits?
PatientReceived no prior treatments
Recent research and studies
EndocrinologyJournal
Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes
Kaneko, Shizuka, and Division of Diabetes/Endocrinology/Lifestyle-Related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan. 2022. “Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes”. Endocrinology. Touch Medical Media, Ltd.. doi:10.17925/ee.2022.18.1.10.
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
2020. "A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04255433.
All > Type 2 Diabetes > Cardiovascular
~1279 spots leftby Oct 2024
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