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

16 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

600

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Part A: Placebo
Placebo as an add-on to diet and exercise.
Droga: Placebo
Placebo
Sperimentale: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906
Sperimentale: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906
Comparatore placebo: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Droga: Placebo
Placebo
Sperimentale: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906
Sperimentale: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906
Comparatore placebo: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Placebo
Placebo
Sperimentale: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906
Sperimentale: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Survodutide
Survodutide
Altri nomi:
  • BI456906

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Lasso di tempo: At baseline and Week 41.
At baseline and Week 41.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Lasso di tempo: At baseline and Week 41.
At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Lasso di tempo: At Week 41.
At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Lasso di tempo: 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
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Lasso di tempo: At baseline and Week 53.
At baseline and Week 53.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 agosto 2026

Completamento primario (Stimato)

17 gennaio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

5 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2026

Primo Inserito (Effettivo)

10 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1404-0115

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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