A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoehringer Ingelheim
About this trial
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.
Eligibility criteria
Qualifiers
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
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Placebo
- Survodutide
Treatment groups
600 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov