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Clinical Trial Details

Trial ID: L4119
Source ID: NCT01129258
Associated Drug: Pf-04991532
Title: Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Diabetes Mellitus, Type 2|Glucose Metabolism Disorders
Interventions: DRUG: PF-04991532|DRUG: Placebo
Outcome Measures: Primary: Safety Endpoints: Safety and tolerability of PF-04991532 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements., 5 months|Single-Dose PK Endpoints for PF-04991352: Cmax, Tmax, and AUC(0-tau)., 5 months|Multiple-Dose PK Endpoints for PF-04991532: Cmax(ss), Tmax(ss), AUC(0-tau,ss), AUC(0-last), half-life, Cmin(ss), Cav(ss), Ae%, CL/F, Vz/F, CLrenal; accumulation ratios AUC(0-tau,ss)/AUC(0-tau,sd) and Cmax(ss)/Cmax(sd), as the data permit., 5 months|PD Endpoint: glucose excursion (change from Day -1 baseline) in response to a liquid meal test (MMTT) on Days 1 and 14., 5 months | Secondary: Insulin and C-peptide (changes from Day -1 baseline) during an MMTT on Days 1 and 14., 5 months|Mean daily glucose (change from Day -1 baseline) on Days 1 and 14., 5 months|Fasting plasma glucose (change from Day -1 baseline) on Days 1, 3, 6, 10, and 14., 5 months|Lipids (change from Day -1 baseline), including: TG, TC, HDL-cholesterol, LDL-cholesterol, FFA, beta-OHB, and ACAC, at times specified in the SOA., 5 months|Lactate (change from Day -1 baseline), at times specified in the SOA., 5 months
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 110
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
Start Date: 2010-06
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2011-03-09
Locations: Pfizer Investigational Site, Chula Vista, California, 91911, United States|Pfizer Investigational Site, Fountain Valley, California, 92708, United States|Pfizer Investigational Site, Miami, Florida, 33169, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT01129258