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A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH) 第IV相・フェーズ4 282

完了
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治験番号 NCT05564039 (SURPASS-SWITCH) は 治療 の研究で、2型糖尿病 を対象とした 第IV相・フェーズ4 介入研究 臨床試験 でした。現在は 完了 です。2022年11月30日 に開始し、282 名の参加者 が参加しました。この試験は イーライリリー によって主導され、2024年8月12日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年8月3日 です。
概要
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.
公式タイトル

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

疾患名
2型糖尿病
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • SURPASS-SWITCH
  • 18395
  • I8F-MC-GPIH (その他の識別子) (Eli Lilly and Company)
  • 2022-500101-41-00 (その他の識別子) (EU Trial Number)
NCT番号
NCT05564039
開始日
2022-11-30
最終更新日
2025-08-03
終了予定日
2024-08-12
目標参加者数
282
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
完了
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)
Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.
Tirzepatide
Administered SC
実薬対照薬4.5 mg Dulaglutide or MTD
Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Dulaglutide
Administered SC
主要評価項目
評価指標指標の説明時間枠
Change From Baseline in HbA1c
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 40
副次評価項目
評価指標指標の説明時間枠
Change From Baseline in Body Weight
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction.
Week 40
Percentage of Participants Who Achieved HbA1c <=6.5%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Week 40
Percentage of Participants Who Achieved HbA1c <5.7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Week 40
Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)
A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment\*Time. For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment\*Time.
Week 40
Change From Baseline in Fasting Serum Glucose (FSG)
LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares).
Baseline, Week 40
Change From Baseline in Waist Circumference
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 40
Change From Baseline in Body Mass Index (BMI)
Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 40
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.'
Baseline, Week 40
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • 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)

  • 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

Eli Lilly and Company logoイーライリリー362 件のアクティブな治験を探索
連絡先情報がありません。
38 5カ国の場所

Florida

ALL Medical Research, LLC, Cooper City, Florida, 33024, United States
Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States

Illinois

NorthShore University Health System, Skokie, Illinois, 60077, United States

Iowa

Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States

Missouri

Clinvest Research LLC, Springfield, Missouri, 65807, United States

Oklahoma

Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States

Texas

Juno Research, Houston, Texas, 77040, United States
Biopharma Informatic, LLC, Houston, Texas, 77043, United States
Juno Research, Houston, Texas, 77054, United States
Southern Endocrinology Associates, Mesquite, Texas, 75149, United States
North Hills Family Medicine/North Hills Medical Research, North Richland Hills, Texas, 76180, United States

Antwerpen

Imelda General Hospital, Bonheiden, Antwerpen, 2820, Belgium
Antwerp University Hospital, Edegem, Antwerpen, 2650, Belgium

Flanders

ZNA Jan Palfijn, Merksem, Flanders, 2170, Belgium

Oost-Vlaanderen

AZ Nikolaas, Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

Vlaams-Brabant

UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

West-Vlaanderen

Az Damiaan vzw, Ostend, West-Vlaanderen, 8400, Belgium

North Rhine-Westphalia

InnoDiab Forschung Gmbh, Essen, North Rhine-Westphalia, 45136, Germany
Institut für Diabetesforschung GmbH Münster, Münster, North Rhine-Westphalia, 48145, Germany

Saxony

Studienzentrum Dr. Tasso Bieler, Riesa, Saxony, 01589, Germany

Schleswig-Holstein

RED-Institut GmbH, Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

State of Berlin

Medizinisches Versorgungszentrum am Bahnhof Spandau, Spandau, State of Berlin, 13597, Germany
Diabeteszentrum Hamburg West, Hamburg, 22607, Germany

Jalisco

Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA, Guadalajara, Jalisco, 44670, Mexico

Mexico City

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Mexico City, 11650, Mexico

Morelos

Instituto de Diabetes, Obesidad y Nutricion, Cuernavaca, Morelos, 62250, Mexico

Nuevo León

Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 64460, Mexico
Unidad biomedica avanzada monterrey, Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico

Tamaulipas

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, Ciudad Madero, Tamaulipas, 89440, Mexico
Investigacion En Salud Y Metabolismo Sc, Chihuahua City, 31217, Mexico

Bihor County

Diabdana, Oradea, Bihor County, 410147, Romania

Brașov County

Mariodiab Clinic, Brasov, Brașov County, 500097, Romania

București

Geea Medical Easy Diet, Bucharest, București, 010627, Romania

Constanța County

Gama Diamed, Mangalia, Constanța County, 905500, Romania

Maramureş

CMI DNBM Dr. Pop Lavinia, Baia Mare, Maramureş, 430222, Romania
Clinica Korall, Satu Mare, 440055, Romania