Clinical trial

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

Recruiting now · Phase 3 · 6 countries · Registry ID NCT07754461

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes

Full registry criteria

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.

Treatments and study arms

Placebo

Drug

Placebo

Survodutide

Drug

Survodutide

Primary outcomes

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

Study locations

121 locations were listed when this page was built. The first 40 are shown.

Royal Prince Alfred Hospital🇦🇺 Camperdown, New South Wales, Australia
Boehringer IngelheimContact
Logan Hospital🇦🇺 Meadowbrook, Queensland, Australia
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Baker Heart and Diabetes Institute🇦🇺 Melbourne, Victoria, Australia
Boehringer IngelheimContact
Southern Adelaide Diabetes & Endocrine services🇦🇺 Oaklands Park, South Australia, Australia
Boehringer IngelheimContact
Centricity Research (Brampton)🇨🇦 Brampton, Ontario, Canada
Boehringer IngelheimContact
Centricity Research (Vaughan)🇨🇦 Concord, Ontario, Canada
Boehringer IngelheimContact
Applied Medical Informatics Research Inc.🇨🇦 Montreal, Quebec, Canada
Boehringer IngelheimContact
Endocrinologie Oasis Inc🇨🇦 Montreal, Quebec, Canada
Boehringer IngelheimContact
Centricity Research (Nepean)🇨🇦 Nepean, Ontario, Canada
Boehringer IngelheimContact
Fraser Clinical Trials🇨🇦 New Westminster, British Columbia, Canada
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Recherche Clinique Sigma Inc.🇨🇦 Québec, Canada
Boehringer IngelheimContact
Albion Finch Medical Centre🇨🇦 Toronto, Ontario, Canada
Boehringer IngelheimContact
Centricity Research (Bayview)🇨🇦 Toronto, Ontario, Canada
Boehringer IngelheimContact
Diabetes Heart Research Centre🇨🇦 Toronto, Ontario, Canada
Boehringer IngelheimContact
Gujarat Endocrine Centre🇮🇳 Ahmedabad, India
Boehringer IngelheimContact
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research🇮🇳 Ahmedabad, India
Boehringer IngelheimContact
AIIMS Bhubaneshwar🇮🇳 Bhubaneswar, India
Boehringer IngelheimContact
S.C.B. Medical College & Hospital🇮🇳 Cuttack, India
Boehringer IngelheimContact
Osmania Medical College & Hospital🇮🇳 Hyderabad, Afzalgunj, India
Boehringer IngelheimContact
Shree Mahalaxmi Diatone Institute🇮🇳 Kolhāpur, India
Boehringer IngelheimContact
Sanjay Gandhi Post Graduate Institute of Medical Sciences🇮🇳 Lucknow, India
Boehringer IngelheimContact
Diabetes Care and Research Centre🇮🇳 Nagpur, India
Boehringer IngelheimContact
Supe Heart & Diabetes Hospital & Research Centre🇮🇳 Nashik, India
Boehringer IngelheimContact
AIIMS, New Delhi🇮🇳 New Delhi, India
Boehringer IngelheimContact
Deenanath Mangeshkar Hospital and Research Centre🇮🇳 Pune, India
Boehringer IngelheimContact
Jothydev's Diabetes Research Centre🇮🇳 Trivandrum, India
Boehringer IngelheimContact
Vishakha Institute of Medical Sciences🇮🇳 Visakhapatnam, India
Boehringer IngelheimContact
Waitemata Clinical Research🇳🇿 Auckland, New Zealand
Boehringer IngelheimContact
Momentum Clinical Research Dunedin🇳🇿 Central Dunedin, Dunedin, New Zealand
Boehringer IngelheimContact
New Zealand Clinical Research (NZCR) Christchurch🇳🇿 Christchurch Central City, Christchurch, New Zealand
Boehringer IngelheimContact
Clinical Trials New Zealand Ltd🇳🇿 Hamilton, New Zealand
Boehringer IngelheimContact
Isis Clinical Research Center🇵🇷 Guaynabo, Puerto Rico
Boehringer IngelheimContact
Albuquerque Clinical Trials🇺🇸 Albuquerque, New Mexico, United States
Boehringer IngelheimContact
Texas Diabetes and Endocrinology🇺🇸 Austin, Texas, United States
Boehringer IngelheimContact
Heritage Valley Medical Group🇺🇸 Beaver, Pennsylvania, United States
Boehringer IngelheimContact
Cahaba Research, Inc. - Trussville Location🇺🇸 Birmingham, Alabama, United States
Boehringer IngelheimContact
Elite Clinical Trials - Blackfoot🇺🇸 Blackfoot, Idaho, United States
Boehringer IngelheimContact
PanAmerican Clinical Research - Bluffton🇺🇸 Bluffton, South Carolina, United States
Boehringer IngelheimContact
Ellipsis Research Group - Brooklyn🇺🇸 Brooklyn, New York, United States
Boehringer IngelheimContact
South Texas Research Institute - Brownsville🇺🇸 Brownsville, Texas, United States
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