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Glucagon-like peptide-1 receptor agonist
Tirzepatide for Type 2 Diabetes (SURPASS-SWITCH Trial)
Phase 4
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 type 2 diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights
SURPASS-SWITCH Trial Summary
This trial is testing whether a different diabetes medication is more effective and has fewer side effects than increasing the dose of the current medication.
Who is the study for?
Adults with type 2 diabetes currently on a stable dose of dulaglutide can join this trial. They should have an HbA1c level between ≥7.0% and ≤9.5%, a BMI of ≥25 kg/m², and may be taking up to three other oral diabetes medications. Exclusions include severe heart failure, very low kidney function, history of pancreatitis or certain thyroid cancers, type 1 diabetes, serious eye problems due to diabetes, recent cardiovascular events or weight loss treatments.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of switching from weekly doses of dulaglutide to tirzepatide in comparison to increasing the dose of dulaglutide for adults with type 2 diabetes. Participants will either switch medication or receive higher doses.See study design
What are the potential side effects?
Possible side effects might include digestive issues like nausea or diarrhea, potential allergic reactions at injection sites, increased risk for pancreatitis and thyroid tumors based on similar drugs' profiles.
SURPASS-SWITCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes.
SURPASS-SWITCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
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
Hypoglycemia
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Fasting Serum Glucose (FSG)
+9 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-SWITCH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC)
Group II: DulaglutideActive Control1 Intervention
Participants will escalate their dulaglutide dose SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5560
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,547 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of pancreatitis.You have type 1 diabetes.I have a serious diabetic eye condition needing immediate treatment.I had to lower my dulaglutide dose because it was too harsh, and couldn't increase it again.I have severe heart failure that limits my daily activities.My kidney function is significantly reduced.I have a history of medullary thyroid cancer or MEN2 in my family or myself.I have used weight loss medications in the last 90 days.I haven't taken, or have been on a stable dose of up to 3 diabetes medications for 3 months.I have been taking a stable dose of dulaglutide weekly for at least 6 months.I have been on insulin before, except for pregnancy diabetes or short-term acute conditions.I have not had a heart attack, stroke, or heart failure hospitalization in the last 2 months.I have type 2 diabetes.You weigh more than what is considered healthy for your height.Your HbA1c level is between 7.0% and 9.5%.Your weight has stayed about the same for the past 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
- Group 2: Dulaglutide
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues are actively conducting this experiment?
"Clinvest Research LLC in Springfield, Missouri, Metabolic Research Institute, Inc. in West Palm Beach, Florida and NorthShore University Health System in Skokie, Illinois are all sites observing this trial with an additional 10 locations also recruiting patients."
Answered by AI
Are there opportunities to become involved in this research project currently available?
"The clinical trial hosted on clinicaltrials.gov is not currently enrolling participants; the protocol was initially posted on December 8th 2022 and last edited November 23rd, 2022. However, there are 1,440 trials actively searching for candidates at this moment."
Answered by AI
Has the FDA sanctioned Tirzepatide for medicinal use?
"Thanks to the completion of a Phase 4 trial, Tirzepatide was deemed safe and given a score 3 out of 3."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Illinois
Texas
What site did they apply to?
ALL Medical Research, LLC
Juno Research
Biopharma Informatic, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
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