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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01469065
First received: October 25, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: PF-04991532
Drug: PF-0499132
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A 2-week, Phase 1, Placebo-Controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Oral Doses Of PF-04991532 Given As Monotherapy To Adult Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability data (number of subjects wtih adverse events, and changes from baseline in standard safety laboratory tests, pulse rate, blood pressure, and ECG measurements over 14 days) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Glucose response (Day 14 versus Day -1 baseline) for mean daily glucose (MDG; average of 8 timepoints throughout the day) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Profile of pharmacokinetics; timeframe: 0, 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, and 18 hours (post dosing Days 1 and 14), and 24, 36, and 48 hours (post dosing Day 14). Parameters: Cmax, area under the curve over 24 hours (AUC24), Tmax [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Glucose response (Day 13 versus Day -2 baseline) for mean daily glucose (MDG; average of 8 timepoints throughout the day) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Glucose response (Day 14 versus Day -1 baseline) for a mixed meal tolerance test (MMTT) glucose area under the curve (AUC) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Glucose response (Days 1, 3, 6, 10, and 14 versus baseline) for fasting plasma glucose (FPG) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Insulin and C-peptide responses (Day 14 versus baseline) during a mixed meal tolerance test (MMTT) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Standard lipid panel characterization (post-treatment Days vs. baseline) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04991532
PF-04991532 experimental study medication
 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
Placebo Comparator: Placebo
PF-04991532 Matching Placebo
 Drug: Placebo
Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469065

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Japan
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01469065     History of Changes
Other Study ID Numbers: B2611005
Study First Received: October 25, 2011
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
inpatient
diabetes
phase 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013