A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS

Registration

Registration

NCT03538743

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

98

Start

2018-06-25

Primary completion

2019-05-23

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 All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) [From baseline to up to 35 days after last dose for a total of approximately 63 days]
• Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality [From baseline to up to 14 days after last dose for a total of approximately 42 days]
• Number of Participants With Abnormal Vital Signs [From baseline to up to 14 days after last dose for a total of approximately 42 days]
• Number of Participants With Abnormal Electrocardiogram (ECG) Interval [From baseline to up to 14 days after last dose for a total of approximately 42 days]