Primary outcomeLeast squares mean· Baseline, Week 12
Change From Baseline in Hemoglobin A1c (HbA1c)
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -0.43 | 0.05 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
NCTNCT05706506 (opens ClinicalTrials.gov in a new tab)Other id18520Other idI8F-MC-GPILOther id2022-002708-18
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 152 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 8 Mar 2023
- Primary completion
- 31 Oct 2023
- Completion
- 31 Oct 2023
- First posted
- 31 Jan 2023
- Last update posted
- 13 Dec 2024
- Conditions
- Type 2 Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20232024
- Ph 4
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
NCT057065068 Mar 2023 to 31 Oct 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- TirzepatideDrug
Arms1
Experimental
5 milligrams (mg) Tirzepatide
Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 12
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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))
Time frame · Baseline, Week 4
Registry description
Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed.
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
Registry description
Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed.
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
Registry description
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed.
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
Registry description
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame · Baseline, Week 12
Registry description
Change from Baseline in FSG was assessed.
Change From Baseline in Weight
Time frame · Baseline, Week 12
Registry description
Change from Baseline in Weight was assessed.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Baseline, Week 4
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))
| Group | Value (Percentage of time per day) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -6.52 | 1.55 |
Secondary outcomeLeast squares mean· Baseline, Week 12
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
| Group | Value (Percentage of time per day) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -7.37 | 1.54 |
Secondary outcomeLeast squares mean· 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)
| Group | Value (Minutes per day) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -93.82 | 22.30 |
Secondary outcomeLeast squares mean· 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)
| Group | Value (Minutes per day) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -106.09 | 22.21 |
Secondary outcomeLeast squares mean· Baseline, Week 12
Change From Baseline in Fasting Serum Glucose (FSG)
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -7.83 | 2.85 |
Secondary outcomeLeast squares mean· Baseline, Week 12
Change From Baseline in Weight
| Group | Value (kilograms (kg)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -2.15 | 0.28 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 5 mg TirzepatideParticipants received 5 mg tirzepatide SC administered QW for 12 weeks. | 0 / 152 | 1 / 152 | 0 / 152 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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.
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