CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 301 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
25 mg PF-04991532from 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/NCT01338870
NCT01338870Phase 2Completed
CompareCT.gov

A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Pfizer·interventional·Posted Apr 20, 2011·Updated Apr 23, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo, 25 mg PF-04991532, and 4 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 301 participants across 42 sites in 6 countries.

Detailed Summary

B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, Hungary, Mexico, Slovakia, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.2 years ago

Interventions

Placebodrug

Tablets (n=4), 0 mg twice daily for 84 days

25 mg PF-04991532drug

Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days

75 mg PF-04991532drug

Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days

150 mg PF-04991532drug

Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days

300 mg PF-04991532drug

Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days

Sitagliptin 100 mgdrug

Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.