A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dulaglutide; Drug: Tirzepatide

• Registration Number: NCT05564039
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-03
• Study Start: 2022-11-30
• Primary Completion: 2024-07-15
• Status Verified: 2024-08
• Study Completion: 2024-08-12
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Have type 2 diabetes
• Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
• Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
• No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
• Have had stable body weight (±5%) during the 90 days preceding screening
• Have BMI ≥25 kilogram/square meter (kg/m²)

Exclusion Criteria

• Have type 1 diabetes

• Have a history of chronic or acute pancreatitis

• Have a history of

  • proliferative diabetic retinopathy, or
  • diabetic maculopathy, or
  • nonproliferative diabetic retinopathy that requires acute treatment.

• Have any of these cardiovascular (CV) conditions within 60 days prior to screening:

  • acute myocardial infarction,
  • cerebrovascular accident (stroke), or
  • hospitalization due to congestive heart failure (CHF).

• Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF

• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).

• 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

• Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)

• Have been treated with insulin prior to screening

  • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

• Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dulaglutide	Dulaglutide	Participants will escalate their dulaglutide dose SC.
Tirzepatide	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Weight	Baseline, Week 40
Percentage of Participants Who Achieve HbA1c <7%	Baseline to Week 40
Percentage of Participants Who Achieve HbA1c ≤6.5%	Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%	Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from baseline of ≥15%	Baseline to Week 40
Percentage of Participants Who Achieve HbA1c <5.7%	Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from baseline of ≥10%	Baseline to Week 40
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia	Week 40	A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) \<54 milligram/deciliter (mg/dL) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
Change from Baseline in Fasting Serum Glucose (FSG)	Baseline, Week 40
Change from Baseline in Waist Circumference	Baseline, Week 40
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 40
Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score	Baseline, Week 40

Trial Locations

Locations (36)

Juno Research; 🇺🇸 Houston, Texas, United States

Biopharma Informatic, LLC; 🇺🇸 Houston, Texas, United States

Diabdana; 🇷🇴 Oradea, Bihor, Romania

ALL Medical Research, LLC; 🇺🇸 Cooper City, Florida, United States

Metabolic Research Institute, Inc.; 🇺🇸 West Palm Beach, Florida, United States

NorthShore University Health System; 🇺🇸 Skokie, Illinois, United States

Clinvest Research LLC; 🇺🇸 Springfield, Missouri, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Southern Endocrinology Associates; 🇺🇸 Mesquite, Texas, United States

North Hills Family Medicine/North Hills Medical Research; 🇺🇸 North Richland Hills, Texas, United States

Az Damiaan vzw; 🇧🇪 Oostende, West-Vlaanderen, Belgium

RED-Institut GmbH; 🇩🇪 Oldenburg, Schleswig-Holstein, Germany

InnoDiab Forschung Gmbh; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Diabeteszentrum Hamburg West; 🇩🇪 Hamburg, Germany

Studienzentrum Dr. Tasso Bieler; 🇩🇪 Riesa, Sachsen, Germany

Institut für Diabetesforschung GmbH Münster; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Unidad de Investigación Clínica y Atención Médica HEPA; 🇲🇽 Guadalajara, Jalisco, Mexico

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares; 🇲🇽 Mexico City, Distrito Federal, Mexico

Gama Diamed; 🇷🇴 Mangalia, Constanța, Romania

CMI DNBM Dr. Pop Lavinia; 🇷🇴 Baia Mare, Maramureș, Romania

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares; 🇲🇽 Ciudad Madero, Tamaulipas, Mexico

ZNA Jan Palfijn; 🇧🇪 Merksem, Vlaams Gewest, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Unidad biomedica avanzada monterrey; 🇲🇽 Monterrey, Nuevo León, Mexico

Investigacion En Salud Y Metabolismo Sc; 🇲🇽 Chihuahua, Mexico

Mariodiab Clinic; 🇷🇴 Brasov, Brașov, Romania

Antwerp University Hospital; 🇧🇪 Edegem, Antwerpen, Belgium

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"; 🇲🇽 Monterrey, Nuevo León, Mexico

Medizinisches Versorgungszentrum am Bahnhof Spandau; 🇩🇪 Spandau, Berlin, Germany

Instituto de Diabetes, Obesidad y Nutricion; 🇲🇽 Cuernavaca, Morelos, Mexico

Imelda General Hospital; 🇧🇪 Bonheiden, Antwerpen, Belgium

Geea Medical Easy Diet; 🇷🇴 Bucharest, București, Romania

Clinica Korall; 🇷🇴 Satu Mare, Romania

Diseno y Planeacion en Investigacion Medica; 🇲🇽 Guadalajara, Jalisco, Mexico