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Glucagon-like peptide-1 receptor agonist
Tirzepatide for Type 2 Diabetes (SURPASS-EARLY Trial)
Verified Trial
Phase 4
Recruiting
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 you been diagnosed with type II diabetes?
Are you currently being treated with only metformin, or are you willing to start?
Must not have
Have you been diagnosed with or treated for cancer in the past 5 years, excluding skin cancer?
Are you taking insulin or any other anti-diabetic medications?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 208
Awards & highlights
SURPASS-EARLY Trial Summary
This trial will compare the effectiveness of tirzepatide versus other diabetes treatments when started early.
Who is the study for?
Adults with type 2 diabetes who have been diagnosed within the last 4 years, currently treated only with metformin, and have HbA1c levels between ≥7% to ≤9.5%. They must not be on insulin or other anti-diabetic meds, have a history of certain thyroid cancers or syndromes (MTC/MEN2), pancreatitis, recent cancer treatments (except skin cancer), weight loss surgery, or severe diabetic eye disease.Check my eligibility
What is being tested?
The trial is testing Tirzepatide's effectiveness and safety against standard care in adults with early-stage type 2 diabetes. Participants will either receive Tirzepatide or intensified conventional antihyperglycemic medication to compare outcomes.See study design
What are the potential side effects?
Tirzepatide may cause side effects such as nausea, vomiting, diarrhea, decreased appetite leading to weight loss; there could also be potential risks for thyroid tumors and inflammation of the pancreas.
SURPASS-EARLY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type II diabetes.
Select...
I am currently taking metformin or willing to start it.
Select...
I was diagnosed with type 2 diabetes in the last 4 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had cancer, except for skin cancer, in the last 5 years.
Select...
I am taking insulin or other medications for diabetes.
Select...
I have had weight loss surgery.
SURPASS-EARLY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 208
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 208
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Change from Baseline in FSG
Change from Baseline in Fasting Serum Glucose (FSG)
+19 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
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-EARLY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Group II: Intensified Conventional Care DoseActive Control1 Intervention
Participants will receive an antihyperglycemic medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5780
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,619 Previous Clinical Trials
3,205,819 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
404,965 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking only metformin for at least 90 days.I have been taking metformin consistently for over 90 days.I was diagnosed with type 2 diabetes in the last 4 years.I or a family member have had medullary thyroid cancer or MEN2.I am taking insulin or other medications for diabetes.I have been diagnosed with pancreatitis before.I have not had cancer, except for skin cancer, in the last 5 years.I have had weight loss surgery.I have a history of eye problems due to diabetes.I am currently taking metformin or willing to start it.I was diagnosed with type 2 diabetes in the last 4 years.I have been diagnosed with type II diabetes.I am taking a medication dose of at least 1500 mg/day, unless I can't tolerate it.You have HbA1c between 7% and 9.5% as determined by the central laboratory.I was diagnosed with type 2 diabetes in the last 4 years.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
- Group 2: Intensified Conventional Care Dose
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05433584 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How detrimental can the use of Tirzepatide be to one's health?
"There is established evidence supporting the safety of Tirzepatide, thus it received a rating of 3."
Answered by AI
Are there still opportunities for patients to participate in this trial?
"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was originally posted on August 1st 2022 is currently seeking applicants. This trial needs to enrol 780 individuals across 39 sites for it to be completed successfully."
Answered by AI
How many participants have been enrolled in this clinical trial thus far?
"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting patients and was first posted on August 1st 2022. Currently 780 individuals need to be recruited from 39 sites for the trial's completion."
Answered by AI
Are there numerous locations implementing this experiment within the confines of our state?
"39 clinical trial sites are currently taking part in this research, such as 9109-0126 Quebec Inc. in Montreal, Lucas Research, Inc in Morehead City, and Bluewater Clinical Research Group Inc. in Sarnia. A full list of participating locations is available.."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Other
Pennsylvania
California
How old are they?
18 - 65
What site did they apply to?
Emory University School of Medicine- Grady Campus
Velocity Clinical Research, Panorama City
Clinical Research of Philadelphia
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I have used Metforman. I want to be healthier. Learn more about diabetes. See if I can lower my a1c.
PatientReceived 2+ prior treatments
I have very bad neuropathy.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is this study? How long do screening visits take? Do the screenings come with possible solutions?
PatientReceived 2+ prior treatments
How long will I have to be in Philadelphia and how many visits? Only how many times will I need to come or will I stay there or drive back and forth please?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Velocity Clinical Research, Panorama City: < 24 hours
- Clinical Research of Philadelphia: < 48 hours
Average response time
- < 2 Days
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