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Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

NCT01338870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2013-04-23

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

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

DRUG

25 mg PF-04991532

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

DRUG

75 mg PF-04991532

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

DRUG

150 mg PF-04991532

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

DRUG

300 mg PF-04991532

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

DRUG

Sitagliptin 100 mg

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Canada
  • Hungary
  • Mexico
  • Slovakia
  • Taiwan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338870 on ClinicalTrials.gov