Study S001191

A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE

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

Registration

Registration: NCT03985293
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 412
Start: 2019-10-15
Primary completion: 2021-06-08
Lead sponsor: Pfizer
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Placebo; DRUG:PF-06882961
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2019-000218-12; NIH:2019

Registered primary outcomes

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 [Baseline, Week 16]

Linked records (1)

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
R0006095	Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. Saxena AR, JAMA network open	2023	Randomized trial	PMID 37213102 DOI	cites ClinicalTrials.gov:NCT03985293; registry reference DERIVED:37213102