Study S001336

AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS

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

Registration

Registration: NCT04552470
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 37
Start: 2020-10-26
Primary completion: 2021-03-25
Lead sponsor: Pfizer
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Placebo; DRUG:PF-06882961
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)]
Number of Participants With Clinical Laboratory Abnormalities [Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)]
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline [Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)]
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline [Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)]

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