Type 2 DiabetesPhase 4NCT05706506
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
A Phase 4 study testing Tirzepatide in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 32 sites in United States.
Trial summary
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 32 sitesUnited States
- Study dates
- 8 Mar 2023to 31 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Type 2 diabetes (T2D)
- Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)
- Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening
- Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months
- No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
Who cannot join
- Have Type 1 Diabetes (T1D)
- Have a clinical history of
- proliferative diabetic retinopathy
- diabetic maculopathy, or
- non-proliferative diabetic retinopathy that requires acute treatment
- Are at high risk for cardiovascular disease or have a history of
Show all 16Show fewer
- myocardial infarction
- percutaneous coronary revascularization procedure
- carotid stenting or surgical revascularization
- nontraumatic amputation
- peripheral vascular procedure
- cerebrovascular accident
- or hospitalization for congestive heart failure
- Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure
- Have a history of ketoacidosis or hyperosmolar state or coma
- Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731-4309
Clinical Research Professionals
Chesterfield, Missouri, 63005
New Hope Research Development
Corona, California, 92882
North Texas Endocrine Center
Dallas, Texas, 75231
Conrad Clinical Research
Edmond, Oklahoma, 73013
Velocity Clinical Research, Gardena
Gardena, California, 90247
Mountain View Clinical Research, Inc.
Greenville, South Carolina, 29607
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Memorial City Endocrine Consultants
Houston, Texas, 77043-2742
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
Georgia Clinical Research
Lawrenceville, Georgia, 30044-5896
Velocity Clinical Research, Huntington Park
Los Angeles, California, 90057
Advanced Medical Research
Maumee, Ohio, 43537-9402
Valley Clinical Trials, Inc.
Northridge, California, 91325
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825
Dream Team Clinical Research
Pomona, California, 91767
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Scripps Whittier Diabetes Institute
San Diego, California, 92121-1520
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
New Tampa Health
Tampa, Florida, 33603-3402
Metabolic Institute of America
Tarzana, California, 91356-3551
Fiel Family and Sports Medicine PC
Tempe, Arizona, 85283
Cotton O'Neil Clinic
Topeka, Kansas, 66606
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
Versailles Family Medicine
Versailles, Kentucky, 40383-1947
CMR of Greater New Haven, LLC
Waterbury, Connecticut, 06708
ClinPoint Trials
Waxahachie, Texas, 75165
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
About this study
Official title: An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults With Type 2 Diabetes Switch From a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2)
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Tirzepatide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 5 milligrams (mg) Tirzepatide | Experimental | Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 12
Secondary outcomes (6)
Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))
Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed.
Measured: Baseline, Week 4
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed.
Measured: Baseline, Week 12
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed.
Measured: Baseline, Week 4
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed.
Measured: Baseline, Week 12
Change From Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in FSG was assessed.
Measured: Baseline, Week 12
Change From Baseline in Weight
Change from Baseline in Weight was assessed.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start8 Mar 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706506
- Sponsor's protocol ID
- 18520
- Other IDs
- I8F-MC-GPIL, 2022-002708-18
- Status last verified
- Dec 2024
- First submitted
- 23 Jan 2023
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults With Type 2 Diabetes Switch From a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2)
- ClinicalTrials.gov ID
- NCT05706506
- Acronym / sponsor ID
- 18520
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 milligrams (mg) Tirzepatide | Experimental | Drug: TirzepatideParticipants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have Type 2 diabetes (T2D)
- Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)
- Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening
- Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months
- No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
Key exclusion criteria (16 listed)
- Have Type 1 Diabetes (T1D)
- Have a clinical history of
- Are at high risk for cardiovascular disease or have a history of
- Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure
- Have a history of ketoacidosis or hyperosmolar state or coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | 5 milligrams (mg) Tirzepatide |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
6 secondary outcomes
Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))
Time frame: Baseline, Week 4
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
Time frame: Baseline, Week 12
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Time frame: Baseline, Week 4
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Time frame: Baseline, Week 12
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame: Baseline, Week 12
Change From Baseline in Weight
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.