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A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

NCT01469065 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2013-10-30

Study results available
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Summary

This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

PF-04991532

Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days

DRUG

PF-04991532

Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days

DRUG

PF-04991532

Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days

DRUG

PF-0499132

Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days

DRUG

Placebo

Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Japan

Study Locations

More Related Trials

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 NCT01469065 on ClinicalTrials.gov