Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Code: PF-00915275
Pharmaceutical Form: Tablet
Current Sponsor code: PF-00915275
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of th
Sponsors
Pfizer Global Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with type 2 diabetes mellitus diagnosed in accordance with the ADA guidelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Recent (within the past 12 months) evidence or history of unstable concomitant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the safety and tolerability of PF-00915275 (10 mg), when administered as tablets to subjects with T2DM for 4 weeks. • To characterize the pharmacokinetics of PF-00915275 following administration of PF-00915275 (10 mg) as tablets to subjects with T2DM for 4 weeks. • To evaluate the pharmacodynamic effect of an oral dose of PF-00915275 (10 mg) on 11ßHSD1 inhibition when administered as tablets for 4-weeks in subjects with T2DM.;Primary end point(s): Pharmacokinetic endpoints: For PF-00915275: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast), area under the concentration-time curve over the dosing interval tau (AUCt), maximum observed plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), terminal phase elimination half-life (t½), apparent oral clearance (CL/F), volume of distribution during the terminal phase (Vz/F). For the PK screen the following endpoints will be determined for PF-00915275: AUClast, area under the concentration-time curve from 0-36 hrs (AUC0-36), area under the concentration-time curve from 0-24 hrs (AUC0-24), Cmax, Tmax, and t½ [if possible]. For prednisone/prednisolone: area under the concentration-time curve from time 0 to 6 hours (AUC0-6), Cmax and Tmax. Safety endpoints: 12-lead ECGs, clinical safety laboratory tests, vital signs, adverse event monitoring, and physical examinations. Pharmacodynamic endpoints (PD): Primary: 24 hour mean daily glucose levels Secondary: Fasting glucose levels, GlycoMarkTM, Hb A1c, total cholesterol, LDL-c, HDL-c, triglycerides, total and high molecular weight adiponectin, high sensitivity C-reactive protein (hsCRP) and insulin will be evaluated in plasma, as well as UFF, UFE, and various urinary cortisol metabolites (including 5a-tetrahydrocortisol, 5ß-tetrahydrocortisol and tetrahydrocortisone); plasma concentrations of prednisone and prednisolone in the presence and absence of PF-00915275. ;Main | — |
Countries
Belgium
Outcome results
None listed