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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
Must not have
Have a history of chronic or acute pancreatitis
Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of pancreatitis.
Select...
I have used weight loss medications in the last 90 days.
Select...
I have a history of medullary thyroid cancer or MEN2 in my family or myself.
Select...
I have a serious diabetic eye condition needing immediate treatment.
Select...
My kidney function is significantly reduced.
Select...
I had to lower my dulaglutide dose because it was too harsh, and couldn't increase it again.
Select...
I have severe heart failure that limits my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Hypoglycemia

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

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.

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
~7520

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,701 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,096 Total Patients Enrolled

Media Library

Tirzepatide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05564039 — Phase 4
Type 2 Diabetes Research Study Groups: Tirzepatide, Dulaglutide
Type 2 Diabetes Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05564039 — Phase 4
Tirzepatide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564039 — Phase 4
~94 spots leftby Dec 2025
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