A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
Recruiting · NCT07754461 · Interventional (participants receive a specific treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSurvodutide
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 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:
- 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);
- 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);
- 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)
- Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
- 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
- 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.
- 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
- Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- 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
- History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
- Body weight change (self-reported) \>5% within 90 days before screening (Visit 1)
- 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).
- 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)
- Further exclusion criteria apply.
Where it is running
60 locations listed across 31 US states.
- Cahaba Research, Inc. - Trussville Location - Birmingham, Alabama, United States
- Mission Research Institute - Gilbert - Gilbert, Arizona, United States
- Helios Clinical Research - Paradise Valley - Paradise Valley, Arizona, United States
- Arizona Liver Health - Peoria 85381 - Peoria, Arizona, United States
- Helios Clinical Research - Phoenix - Phoenix, Arizona, United States
- Woodland International Research Group, Inc. - Little Rock, Arkansas, United States
- San Fernando Valley Health - Canoga Park, California, United States
- John Muir Physician Network Clinical Research Center - Concord, California, United States
- Neighborhood Healthcare - Escondido - Escondido, California, United States
- Clinical Trials Research - Lincoln - Lincoln, California, United States
- ARK Clinical Research - Long Beach, California, United States
- Infinity Clinical Research - Norco, California, United States
- Valley Clinical Trials, Inc. - Northridge, California, United States
- Fomat Medical Research - Oxnard, California, United States
- Encompass Clinical Research, Spring Valley - Spring Valley, California, United States
- University Clinical Investigators, Inc. - Tustin, California, United States
- Diablo Clinical Research - Walnut Creek, California, United States
- Focus Clinical Research - West Hills, California, United States
- Clinical Research of West Florida, Inc. - Clearwater, Florida, United States
- Northeast Research Institute - Fleming Island, Florida, United States
- Covenant Metabolic Specialists, LLC - Fort Myers - Fort Myers, Florida, United States
- Encore Medical Research - Hollywood, Florida, United States
- Northeast Research Institute - Jacksonville, Florida, United States
- Accel Research Sites - Lakeland - Lakeland, Florida, United States
- Clinical Research of Central Florida - Lakeland - Lakeland, Florida, United States
- Tampa Bay Medical Research - Largo - Largo, Florida, United States
- New Horizon Research Center-Miami-69732 - Miami, Florida, United States
- South Broward Research - Miramar, Florida, United States
- Covenant Metabolic Specialists, LLC - Brandon - Riverview, Florida, United States
- Covenant Metabolic Specialists, LLC - Sarasota - University Park, Florida, United States
- Metabolic Research Institute, Inc. - West Palm Beach, Florida, United States
- Encore Medical Research - Weston - Weston, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- Centricity Research, Endocrine Consultants - Columbus, Georgia, United States
- Javara-Fayetteville-67354 - Fayetteville, Georgia, United States
- Balanced Life Health Care Solutions - Lawrenceville, Georgia, United States
- Rophe Adult and Pediatric Medicine - Union City, Georgia, United States
- Pacific Diabetes & Endocrine Center - Honolulu, Hawaii, United States
- Elite Clinical Trials - Blackfoot - Blackfoot, Idaho, United States
- Family First Clinical Research - Idaho Falls, Idaho, United States
- Solaris Clinical Research - Meridian, Idaho, United States
- Evanston Premier Healthcare Research LLC - Skokie, Illinois, United States
- Cotton O'Neil Mulvane - Topeka, Kansas, United States
- AMR Lexington - Lexington, Kentucky, United States
- Endocrine and Metabolic Consultants - Rockville, Maryland, United States
- Northern Pines Health Center - Buckley - Buckley, Michigan, United States
- Revival Research Institute, LLC - Dearborn - Dearborn, Michigan, United States
- Arcturus Healthcare - Troy Internal Medicine Research Division - Troy, Michigan, United States
- International Diabetes Center - Minneapolis, Minnesota, United States
- Olive Branch Family Medical Center - Olive Branch, Mississippi, United States
- SKY Clinical Research Network Group - Ridgeland - Ridgeland, Mississippi, United States
- StudyMetrix Research, LLC - City of Saint Peters, Missouri, United States
- Logan Health Research - Kalispell - Kalispell, Montana, United States
- Boeson Research - Missoula - Missoula, Montana, United States
- Palm Research Center - Las Vegas, Nevada, United States
- Albuquerque Clinical Trials - Albuquerque, New Mexico, United States
- Ellipsis Research Group - Brooklyn - Brooklyn, New York, United States
- Javara Inc. - Cape Fear Valley Medical Center - Fayetteville, North Carolina, United States
- PharmQuest Life Sciences - Greensboro, North Carolina, United States
- Centricity Research - Morehead City - Morehead City, North Carolina, United States
Showing 60 of 121 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →