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A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

16. september 2026 opdateret af: Boehringer Ingelheim

A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join.

The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.

Depending on a person's diabetes treatment, a person will be assigned either to

  • Part A: healthy eating and physical activity
  • Part B: diabetes tablets (no injection of insulin)
  • Part C: injection of insulin (with or without diabetes tablets)

Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.

Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Ikke rekrutterer endnu
        • Royal Prince Alfred Hospital
        • Kontakt:
    • Queensland
      • Meadowbrook, Queensland, Australien, 4131
    • South Australia
      • Oaklands Park, South Australia, Australien, 5046
        • Ikke rekrutterer endnu
        • Southern Adelaide Diabetes & Endocrine services
        • Kontakt:
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Ikke rekrutterer endnu
        • Baker Heart and Diabetes Institute
        • Kontakt:
  • Canada
      • Québec, Canada, G1G 5X1
        • Rekruttering
        • Recherche Clinique Sigma Inc.
        • Kontakt:
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Rekruttering
        • Fraser Clinical Trials
        • Kontakt:
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Rekruttering
        • Centricity Research (Brampton)
        • Kontakt:
      • Concord, Ontario, Canada, L4K 4M2
        • Ikke rekrutterer endnu
        • Centricity Research (Vaughan)
        • Kontakt:
      • Nepean, Ontario, Canada, K2J 0V2
        • Ikke rekrutterer endnu
        • Centricity Research (Nepean)
        • Kontakt:
      • Toronto, Ontario, Canada, M9V 4B4
        • Ikke rekrutterer endnu
        • Albion Finch Medical Centre
        • Kontakt:
      • Toronto, Ontario, Canada, M6G 1M2
        • Ikke rekrutterer endnu
        • Diabetes Heart Research Centre
        • Kontakt:
      • Toronto, Ontario, Canada, M4G 3E8
        • Ikke rekrutterer endnu
        • Centricity Research (Bayview)
        • Kontakt:
    • Quebec
      • Montreal, Quebec, Canada, H4J 1E3
        • Rekruttering
        • Endocrinologie Oasis Inc
        • Kontakt:
      • Montreal, Quebec, Canada, H4A 3T2
        • Ikke rekrutterer endnu
        • Applied Medical Informatics Research Inc.
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35235
        • Ikke rekrutterer endnu
        • Cahaba Research, Inc. - Trussville Location
        • Kontakt:
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85296
        • Ikke rekrutterer endnu
        • Mission Research Institute - Gilbert
        • Kontakt:
      • Paradise Valley, Arizona, Forenede Stater, 85253
        • Ikke rekrutterer endnu
        • Helios Clinical Research - Paradise Valley
        • Kontakt:
      • Peoria, Arizona, Forenede Stater, 85381
        • Ikke rekrutterer endnu
        • Arizona Liver Health - Peoria 85381
        • Kontakt:
      • Phoenix, Arizona, Forenede Stater, 85028
        • Ikke rekrutterer endnu
        • Helios Clinical Research - Phoenix
        • Kontakt:
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Rekruttering
        • Woodland International Research Group, Inc.
        • Kontakt:
    • California
      • Canoga Park, California, Forenede Stater, 91304
      • Concord, California, Forenede Stater, 94520
        • Rekruttering
        • John Muir Physician Network Clinical Research Center
        • Kontakt:
      • Escondido, California, Forenede Stater, 92025
        • Ikke rekrutterer endnu
        • Neighborhood Healthcare - Escondido
        • Kontakt:
      • Lincoln, California, Forenede Stater, 95648
        • Ikke rekrutterer endnu
        • Clinical Trials Research - Lincoln
        • Kontakt:
      • Long Beach, California, Forenede Stater, 90815
      • Norco, California, Forenede Stater, 92860
      • Northridge, California, Forenede Stater, 91325
      • Oxnard, California, Forenede Stater, 93030
      • Spring Valley, California, Forenede Stater, 91978
        • Rekruttering
        • Encompass Clinical Research, Spring Valley
        • Kontakt:
      • Tustin, California, Forenede Stater, 92780
        • Ikke rekrutterer endnu
        • University Clinical Investigators, Inc.
        • Kontakt:
      • Walnut Creek, California, Forenede Stater, 94598
      • West Hills, California, Forenede Stater, 91307
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
      • Fleming Island, Florida, Forenede Stater, 32003
      • Fort Myers, Florida, Forenede Stater, 33912
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Kontakt:
      • Hollywood, Florida, Forenede Stater, 33024
      • Jacksonville, Florida, Forenede Stater, 32204
      • Lakeland, Florida, Forenede Stater, 33803
      • Lakeland, Florida, Forenede Stater, 33805
        • Ikke rekrutterer endnu
        • Clinical Research of Central Florida - Lakeland
        • Kontakt:
      • Largo, Florida, Forenede Stater, 33777
      • Miami, Florida, Forenede Stater, 33165
        • Ikke rekrutterer endnu
        • New Horizon Research Center-Miami-69732
        • Kontakt:
      • Miramar, Florida, Forenede Stater, 33027
      • Riverview, Florida, Forenede Stater, 33578
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Brandon
        • Kontakt:
      • University Park, Florida, Forenede Stater, 34201
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Sarasota
        • Kontakt:
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Ikke rekrutterer endnu
        • Metabolic Research Institute, Inc.
        • Kontakt:
      • Weston, Florida, Forenede Stater, 33331
      • Winter Park, Florida, Forenede Stater, 32789
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31904
        • Rekruttering
        • Centricity Research, Endocrine Consultants
        • Kontakt:
      • Fayetteville, Georgia, Forenede Stater, 30214
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • Ikke rekrutterer endnu
        • Balanced Life Health Care Solutions
        • Kontakt:
      • Union City, Georgia, Forenede Stater, 30291
        • Ikke rekrutterer endnu
        • Rophe Adult and Pediatric Medicine
        • Kontakt:
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Ikke rekrutterer endnu
        • Pacific Diabetes & Endocrine Center
        • Kontakt:
    • Idaho
      • Blackfoot, Idaho, Forenede Stater, 83221
        • Ikke rekrutterer endnu
        • Elite Clinical Trials - Blackfoot
        • Kontakt:
      • Idaho Falls, Idaho, Forenede Stater, 83404
      • Meridian, Idaho, Forenede Stater, 83646
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
        • Ikke rekrutterer endnu
        • Evanston Premier Healthcare Research LLC
        • Kontakt:
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Ikke rekrutterer endnu
        • Endocrine and Metabolic Consultants
        • Kontakt:
    • Michigan
      • Buckley, Michigan, Forenede Stater, 49620
        • Ikke rekrutterer endnu
        • Northern Pines Health Center - Buckley
        • Kontakt:
      • Dearborn, Michigan, Forenede Stater, 48126
        • Rekruttering
        • Revival Research Institute, LLC - Dearborn
        • Kontakt:
      • Troy, Michigan, Forenede Stater, 48098
        • Ikke rekrutterer endnu
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Kontakt:
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55416
    • Mississippi
      • Olive Branch, Mississippi, Forenede Stater, 38654
        • Ikke rekrutterer endnu
        • Olive Branch Family Medical Center
        • Kontakt:
      • Ridgeland, Mississippi, Forenede Stater, 39157
        • Ikke rekrutterer endnu
        • SKY Clinical Research Network Group - Ridgeland
        • Kontakt:
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63303
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • Ikke rekrutterer endnu
        • Logan Health Research - Kalispell
        • Kontakt:
      • Missoula, Montana, Forenede Stater, 59804
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
    • New York
      • Brooklyn, New York, Forenede Stater, 11215
        • Ikke rekrutterer endnu
        • Ellipsis Research Group - Brooklyn
        • Kontakt:
    • North Carolina
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Ikke rekrutterer endnu
        • Javara Inc. - Cape Fear Valley Medical Center
        • Kontakt:
      • Greensboro, North Carolina, Forenede Stater, 27408
      • Morehead City, North Carolina, Forenede Stater, 28557
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Ikke rekrutterer endnu
        • Diabetes & Endocrinology Associates of Stark County
        • Kontakt:
      • Maumee, Ohio, Forenede Stater, 43537
        • Ikke rekrutterer endnu
        • Advanced Medical Research - Maumee
        • Kontakt:
      • Wadsworth, Ohio, Forenede Stater, 44281
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73134
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • Ikke rekrutterer endnu
        • Preferred Primary Care Physicians-Pittsburgh-63932
        • Kontakt:
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • Ikke rekrutterer endnu
        • Preferred Primary Care Physicians
        • Kontakt:
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Ikke rekrutterer endnu
        • Preferred Primary Care Physicians - Matthew Drive
        • Kontakt:
    • South Carolina
      • Bluffton, South Carolina, Forenede Stater, 29910
        • Ikke rekrutterer endnu
        • PanAmerican Clinical Research - Bluffton
        • Kontakt:
      • Spartanburg, South Carolina, Forenede Stater, 29303
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Rekruttering
        • University Diabetes & Endocrine Consultants
        • Kontakt:
      • Memphis, Tennessee, Forenede Stater, 38115
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • Rekruttering
        • Texas Diabetes and Endocrinology - Central Austin
        • Kontakt:
      • Brownsville, Texas, Forenede Stater, 78520
        • Ikke rekrutterer endnu
        • South Texas Research Institute - Brownsville
        • Kontakt:
      • Conroe, Texas, Forenede Stater, 77384
      • Dallas, Texas, Forenede Stater, 75390-8837
        • Ikke rekrutterer endnu
        • University of Texas Southwestern Medical Center
        • Kontakt:
      • Georgetown, Texas, Forenede Stater, 78626
      • Houston, Texas, Forenede Stater, 77040
      • Houston, Texas, Forenede Stater, 77084
        • Ikke rekrutterer endnu
        • Biopharma Informatic, Inc. Research Center
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77089
      • Mesquite, Texas, Forenede Stater, 75149
        • Ikke rekrutterer endnu
        • Southern Endocrinology Associates
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
      • San Antonio, Texas, Forenede Stater, 78222
      • Shavano Park, Texas, Forenede Stater, 78231
      • Weslaco, Texas, Forenede Stater, 78596
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84117
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Ikke rekrutterer endnu
        • Tidewater Physicians Multispecialty Group
        • Kontakt:
    • Washington
      • Redmond, Washington, Forenede Stater, 98052
    • Wisconsin
      • Kenosha, Wisconsin, Forenede Stater, 53144
        • Ikke rekrutterer endnu
        • Clinical Investigation Specialists, Inc.-Kenosha-69111
        • Kontakt:
  • Indien
      • Ahmedabad, Indien, 380006
        • Ikke rekrutterer endnu
        • Gujarat Endocrine Centre
        • Kontakt:
      • Ahmedabad, Indien, 380006
        • Ikke rekrutterer endnu
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Kontakt:
      • Bhubaneswar, Indien, 751019
        • Ikke rekrutterer endnu
        • AIIMS Bhubaneshwar
        • Kontakt:
      • Cuttack, Indien, 753007
        • Ikke rekrutterer endnu
        • S.C.B. Medical College & Hospital
        • Kontakt:
      • Hyderabad, Afzalgunj, Indien, 500012
        • Ikke rekrutterer endnu
        • Osmania Medical College & Hospital
        • Kontakt:
      • Kolhāpur, Indien, 416003
        • Ikke rekrutterer endnu
        • Shree Mahalaxmi Diatone Institute
        • Kontakt:
      • Lucknow, Indien, 226 014
        • Ikke rekrutterer endnu
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Kontakt:
      • Nagpur, Indien, 440010
        • Ikke rekrutterer endnu
        • Diabetes Care and Research Centre
        • Kontakt:
      • Nashik, Indien, 422002
        • Ikke rekrutterer endnu
        • Supe Heart & Diabetes Hospital & Research Centre
        • Kontakt:
      • New Delhi, Indien, 110029
        • Ikke rekrutterer endnu
        • AIIMS, New Delhi
        • Kontakt:
      • Pune, Indien, 411004
        • Ikke rekrutterer endnu
        • Deenanath Mangeshkar Hospital and Research Centre
        • Kontakt:
      • Trivandrum, Indien, 695032
        • Ikke rekrutterer endnu
        • Jothydev's Diabetes Research Centre
        • Kontakt:
      • Visakhapatnam, Indien, 530040
        • Ikke rekrutterer endnu
        • Vishakha Institute of Medical Sciences
        • Kontakt:
  • New Zealand
      • Auckland, New Zealand, 0626
        • Ikke rekrutterer endnu
        • Waitemata Clinical Research
        • Kontakt:
      • Hamilton, New Zealand, 3204
        • Ikke rekrutterer endnu
        • Clinical Trials New Zealand Ltd
        • Kontakt:
    • Christchurch
      • Christchurch Central City, Christchurch, New Zealand, 8011
        • Ikke rekrutterer endnu
        • New Zealand Clinical Research (NZCR) Christchurch
        • Kontakt:
    • Dunedin
      • Central Dunedin, Dunedin, New Zealand, 9016
        • Ikke rekrutterer endnu
        • Momentum Clinical Research Dunedin
        • Kontakt:
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion criteria:

  1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years

  2. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:

    1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol/mol) and <9.5% (<80 mmol/mol) as measured by the central laboratory at screening (Visit 1);
    2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and/or Maximum tolerated dose of sulfonylurea and/or Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol/mol) and <10.5% (<91 mmol/mol) as measured by the central laboratory at screening (Visit 1);
    3. Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)/day with or without stable dose of metformin and/or SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol/mol) and <10.5% (<91 mmol/mol) as measured by the central laboratory at screening (Visit 1)
  3. Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
  4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
  5. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
  6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)

Exclusion criteria:

  1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
  2. Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist/glucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion/naltrexone, orlistat, phentermine, and phentermine/topiramate
  3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
  4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
  5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
  6. Body weight change (self-reported) >5% within 90 days before screening (Visit 1)
  7. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening (Visit 1), (2) lap banding, if the band has been removed >1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed >1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening (Visit 1).
  8. Answered "yes" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)
  9. Further exclusion criteria apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Part A: Placebo
Placebo as an add-on to diet and exercise.
Medicin: Placebo
Placebo
Eksperimentel: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906
Eksperimentel: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906
Placebo komparator: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Medicin: Placebo
Placebo
Eksperimentel: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906
Eksperimentel: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906
Placebo komparator: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Medicin: Placebo
Placebo
Eksperimentel: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906
Eksperimentel: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Medicin: Survodutide
Survodutide
Andre navne:
  • BI 456906

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Tidsramme: At baseline and Week 41.
At baseline and Week 41.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Tidsramme: At baseline and Week 41.
At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Tidsramme: At Week 41.
At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Tidsramme: At baseline and Week 53.
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. august 2026

Primær færdiggørelse (Anslået)

17. januar 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

5. august 2026

Først indsendt, der opfyldte QC-kriterier

5. august 2026

Først opslået (Faktiske)

10. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1404-0115

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-delingsadgangskriterier

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner