Clinical trial NCT05564039: A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Change from Baseline in Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieve HbA1c <7%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieve HbA1c ≤6.5%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieve HbA1c <5.7%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieve Weight loss from baseline of ≥10%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieve Weight loss from baseline of ≥15%
timeFrame: Baseline to Week 40
measure: A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
timeFrame: Week 40
measure: Change from Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 40
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 40
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 40
measure: Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: Bonheiden
country: Belgium
facility: Imelda General Hospital
state: Antwerpen
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Oost-Vlaanderen
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
state: Vlaams Gewest
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Oostende
country: Belgium
facility: Az Damiaan vzw
state: West-Vlaanderen
city: Spandau
country: Germany
facility: Medizinisches Versorgungszentrum am Bahnhof Spandau
state: Berlin
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Riesa
country: Germany
facility: Studienzentrum Dr. Tasso Bieler
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Monterrey
country: Mexico
facility: Unidad biomedica avanzada monterrey
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Tamaulipas
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Oradea
country: Romania
facility: Diabdana
state: Bihor
city: Brasov
country: Romania
facility: Mariodiab Clinic
state: Brașov
city: Bucharest
country: Romania
facility: Geea Medical Easy Diet
state: București
city: Mangalia
country: Romania
facility: Gama Diamed
state: Constanța
city: Baia Mare
country: Romania
facility: CMI DNBM Dr. Pop Lavinia
state: Maramureș
city: Satu Mare
country: Romania
facility: Clinica Korall
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: