Study S000172

A Phase II, Randomized, Parallel Group, Dose-finding Study of Subcutaneously Administered BI 456906 for 16 Weeks, Compared With Placebo and Open-label Semaglutide in Patients With Type 2 Diabetes Mellitus.

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04153929
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 413
Start: 2020-04-30
Primary completion: 2021-10-08
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:BI 456906; DRUG:Placebo; DRUG:Semaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2019-002390-60; NIH:2019

Registered primary outcomes

Absolute Change in HbA1c From Baseline to 16 Weeks [At baseline and at Week 17 (16 weeks after treatment start).]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0005767	Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Ekinci EI, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 42331726 DOI	cites ClinicalTrials.gov:NCT04153929; cites EudraCT:2019-002390-60; registry reference DERIVED:42331726
R0007239	Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial. Blüher M, Diabetologia	2024	Randomized trial	PMID 38095657 DOI	cites ClinicalTrials.gov:NCT04153929; cites EudraCT:2019-002390-60; registry reference DERIVED:38095657
R0049255	1665-P: Analysis of Glucose Biomarkers in Phase I and Phase II Studies of Survodutide in People with Type 2 Diabetes or Living with Overweight/Obesity Elif Ilhan Ekinci, Diabetes	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT04153929