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Completed

NCT Number: NCT05706506

A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fiel Family and Sports Medicine PC, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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) was assessed.

  2. 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 Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed.

  3. 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) was assessed.

  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 Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed.

  5. Change From Baseline in Fasting Serum Glucose (FSG)

    Time frame: Baseline, Week 12

    Change from Baseline in FSG was assessed.

  6. Change From Baseline in Weight

    Time frame: Baseline, Week 12

    Change from Baseline in Weight was assessed.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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