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Clinical Trial Details

Trial ID: L5676
Source ID: NCT01044537
Associated Drug: Placebo
Title: A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01044537/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Placebo|DRUG: PF-04937319
Outcome Measures: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state., Day 1 up to 10 days after last dose of study medication (up to 11 days)|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast)., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Maximum Observed Plasma Concentration (Cmax), 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Time to Reach Maximum Observed Plasma Concentration (Tmax), 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Apparent Oral Clearance (CL/F), Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Apparent Volume of Distribution (Vz/F), Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Plasma Decay Half-Life (t1/2), Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf), AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | Secondary: Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1, Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram\*deciliter\*hour \[ng\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*milliliter\*hour \[mg\*mL\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1., -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1|Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1, Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1., -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1, Percent change from baseline in post-prandial area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1., -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1, Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1., -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1, Ratio of insulin delta C30 (in terms of milliunits\*deciliter \[mU\*dL\]) to glucose delta C30 (in terms of milligram\*liter \[mg\*liter\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1., -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT), Ratio of C-peptide Delta C30 (in terms of nanogram\*deciliter \[ng\*dL\]) to glucose delta C30 (in terms of milligram\*milliliter \[mg\*mL\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1., -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1, Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit\*deciliter\*hour \[mU\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*liter\*hour \[mg\*liter\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1., -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2010-02
Completion Date: 2010-05
Results First Posted: 2017-03-10
Last Update Posted: 2017-03-10
Locations: Dedicated Phase 1, Phoenix, Arizona, 85013, United States|West Coast Clinical Trials, LLC, Cypress, California, 90630, United States|Elite Research Institute, Miami, Florida, 33169, United States
URL: https://clinicaltrials.gov/show/NCT01044537