CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 412 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
PF-06882961 120 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/NCT03985293
NCT03985293Phase 2Completed

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

Pfizer·interventional·Posted Jun 13, 2019·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo and PF-06882961 for Diabetes Mellitus, Type 2. Completed, enrolled 412 participants across 83 sites in 8 countries.

Detailed Summary

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Hungary, Poland, Slovakia, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 13, 2019
Enrollment StartOct 15, 2019
Primary CompletionJun 8, 2021
Study CompletionJul 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago

Interventions

Placebodrug

4 matching placebo tablets taken twice a day (BID)

PF-06882961drug

Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.