A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-04991532; PF-04991532; PF-04991532; PF-0499132; Placebo
Intervention description: Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days
Intervention MeSH terms: Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: inpatient; diabetes; phase 1

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.
    

Eligibility 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.