NCT01469065

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2011

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 29, 2013

Completed
Last Updated

October 30, 2013

Status Verified

September 1, 2013

Enrollment Period

5 months

First QC Date

October 25, 2011

Results QC Date

June 12, 2013

Last Update Submit

September 26, 2013

Conditions

Diabetes Mellitus, Type 2

Keywords

inpatientdiabetesphase 1

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline (Day -1) in Mean Daily Glucose at Day 14

    Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.

    Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose

Secondary Outcomes (18)

  • Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532

    0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14

  • Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532

    0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14

  • Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))

    0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning

  • Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))

    10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14

  • Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532

    Day 14

  • +13 more secondary outcomes

Study Arms (2)

PF-04991532

EXPERIMENTAL

PF-04991532 experimental study medication

Drug: PF-04991532Drug: PF-0499132

Placebo

PLACEBO COMPARATOR

PF-04991532 Matching Placebo

Drug: Placebo

Interventions

PF-04991532DRUG

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

PF-04991532
PF-0499132DRUG

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

PF-04991532
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately 8-10 weeks. For those taking a single OAD, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to Screening. OAD medications that are acceptable to be discontinued include: a sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
  • Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs).
  • HbA1c \>/=7% and \</=10% if the patient is on diet/exercise therapy only and does not require any OAD discontinuation. HbA1c \>/=6.5% and \</=9% if the patient requires to be washed off an OAD.

You may not qualify if:

  • Evidence or history of diabetic complications with significant end organ damage.
  • History of stroke or transient ischemic attack.
  • History of myocardial infarction.
  • History of coronary artery bypass graft or stent implantation.
  • Clinically significant peripheral vascular disease.
  • Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.
  • Current history of angina/unstable angina.
  • One or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
  • A positive urine drug screen.
  • Use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
  • Blood pressure \>/=160 mm Hg (systolic) or \>/=100 mm Hg (diastolic), following at least 5 minutes of rest.
  • Pregnant or nursing females; females of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Chula Vista, California, 91911, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 10, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 30, 2013

Results First Posted

August 29, 2013

Record last verified: 2013-09

Locations

US(2)JP(1)