CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 98 enrolled
Drug / intervention
Placebo +8 moredrug
Likely dose
Placebo 0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03538743
NCT03538743Phase 1Completed

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

Pfizer·interventional·Posted May 29, 2018·Updated Jul 1, 2020

In Brief

A Phase 1 clinical trial evaluating Placebo and PF-06882961 for Type 2 Diabetes Mellitus. Completed, enrolled 98 participants across 4 sites.

Detailed Summary

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartJun 25, 2018
Primary CompletionMay 23, 2019
Study CompletionJun 10, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.1 years ago

Interventions

Placebodrug

Tablet, 0 mg, twice daily, 28 days

PF-06882961drug

Tablet, 15 mg twice daily, 28 days

PF-06882961drug

Tablet, 50 mg twice daily, 28 days

PF-06882961drug

Tablet, 150 mg twice daily, 28 days

PF-06882961drug

Tablet, 300 mg twice daily, 28 days

PF-06882961drug

Tablet, dose TBD, twice daily, Cohort 5, 28 days

PF-06882961drug

Tablet, dose TBD, twice daily, Cohort 6, 28 days

PF-06882961drug

Tablet, dose TBD, twice daily, Cohort 7, 28 days

PF-06882961drug

Tablet, dose TBD, twice daily, Cohort 8, 28 days