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

Type 2 Diabetes Clinical Trial

— SURPASS-SWITCH  

Official title:

A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05564039
• Other study ID #: 18395
• Secondary ID: I8F-MC-GPIH2022-
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 30, 2022
• Est. completion date: August 29, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: August 29, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Dulaglutide
Administered SC

Locations

Country	Name	City	State
Belgium	Imelda General Hospital	Bonheiden	Antwerpen
Belgium	Antwerp University Hospital	Edegem	Antwerpen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	ZNA Jan Palfijn	Merksem	Vlaams Gewest
Belgium	Az Damiaan vzw	Oostende	West-Vlaanderen
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	MVZ Riesa am Klinikum Döbeln GmbH	Riesa	Sachsen
Germany	Medizinisches Versorgungszentrum am Bahnhof Spandau	Spandau	Berlin
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Diseno y Planeacion en Investigacion Medica	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Unidad biomedica avanzada monterrey	Monterrey	Nuevo León
Romania	CMI DNBM Dr. Pop Lavinia	Baia Mare	Maramure?
Romania	Mariodiab Clinic	Brasov	Bra?ov
Romania	Geea Medical Easy Diet	Bucharest	Bucure?ti
Romania	Gama Diamed	Mangalia	Constan?a
Romania	Diabdana	Oradea	Bihor
Romania	Clinica Korall	Satu Mare
United States	ALL Medical Research, LLC	Cooper City	Florida
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Intend Research, LLC	Norman	Oklahoma
United States	North Hills Family Medicine/North Hills Medical Research	North Richland Hills	Texas
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	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Mexico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 40
Secondary	Change from Baseline in Weight		Baseline, Week 40
Secondary	Percentage of Participants Who Achieve HbA1c <7%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieve HbA1c =6.5%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieve HbA1c <5.7%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieve Weight loss from Baseline of =5%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieve Weight loss from baseline of =10%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieve Weight loss from baseline of =15%		Baseline to Week 40
Secondary	A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia	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	Week 40
Secondary	Change from Baseline in Fasting Serum Glucose (FSG)		Baseline, Week 40
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 40
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 40
Secondary	Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score		Baseline, Week 40

External Links

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