Phase 4
N=152
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
Type 2 Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05706506 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Dec 2024
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) — -0.43 Percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tirzepatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.43 | — |
| SECONDARY 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)) |
-6.52 | — |
| SECONDARY Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L) |
-7.37 | — |
| SECONDARY Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) |
-106.09 | — |
| SECONDARY Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) |
-106.09 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) |
-7.83 | — |
| SECONDARY Change From Baseline in Weight |
-2.15 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05706506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.