A Phase 3 interventional study of Placebo and Survodutide in Type 2 Diabetes, sponsored by Boehringer Ingelheim. Recruiting at 101 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
Among 130 studies in Diabetes Mellitus, Type 2 by Boehringer Ingelheim — 2 open to participants now, 3 under way, 2 of them phase 3. Diabetes Mellitus, Type 2 · Boehringer Ingelheim.
Among the 130 studies in Diabetes Mellitus, Type 2 by Boehringer Ingelheim, this one is the 30th largest by planned enrollment of the 96 interventional ones that give a count, is the only one that started in 2026, is one of 50 in phase 3, and was the 130th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →2 of the 130 studies in Diabetes Mellitus, Type 2 by Boehringer Ingelheim are open now, in 12 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Argentina, Australia and 48 more countries
Ages 18+
By country, each count listing its studies:
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
130 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 302 across the 96 interventional studies, 10,286 across the 34 observational. Of the 125 that completed or were terminated, 109 (87%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
1 of the studies in Diabetes Mellitus, Type 2 by Boehringer Ingelheim that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05882071Boehringer IngelheimNon-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France | 2026-11-30 |
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Among the 130 studies in Diabetes Mellitus, Type 2 by Boehringer Ingelheim, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo as an add-on to diet and exercise.
Drug: Placebo
Low-dose survodutide as an add-on to diet and exercise.
Drug: Survodutide
High-dose survodutide as add-on to diet and exercise
Drug: Survodutide
Placebo as an add-on to anti-diabetic drugs.
Drug: Placebo
Low-dose survodutide as an add-on to anti-diabetic drugs.
Drug: Survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Drug: Survodutide
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Placebo
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Survodutide
Placebo
Survodutide
Also known as: BI 456906
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Time frame: At baseline and Week 41.
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Time frame: At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Time frame: At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Time frame: At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Time frame: At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Time frame: At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
Time frame: At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Time frame: At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Time frame: At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Time frame: At baseline and Week 53.
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Plan to share: Yes — 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
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Started Aug 2026 (actual). Primary completion is estimated for Jan 2028, 16 months after the start.
Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 16 months is below that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Survodutide