| Trial ID: | L4676 |
| Source ID: | NCT02175121
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| Associated Drug: |
Placebo
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| Title: |
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02175121/results
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| Conditions: |
Diabetes Mellitus, Type II
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| Interventions: |
DRUG: Placebo|DRUG: PF-06291874|DRUG: PF-06291874|DRUG: PF-06291874|DRUG: PF-06291874
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| Outcome Measures: |
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs), An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state., Baseline up to 10-14 days after last dose of study drug, up to 42 days|Number of Participants With Laboratory Test Abnormalities, The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests., Baseline up to 10-14 days after last dose of study drug, up to 42 days|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern, Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm)., Baseline up to 10-14 days after last dose of study drug, up to 42 days|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern, ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 msec; \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 milliseconds (msec); \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec., Baseline up to 10-14 days after last dose of study drug, up to 42 days | Secondary: Change From Baseline in Mean Daily Glucose, The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28., Baseline and Day 28|Change From Baseline in Fasting Plasma Glucose, Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in Triglycerides, Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in Total Cholesterol, Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C), LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in Non-HDL-C, Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29., Baseline, Day 14 and the mean of Days 28 and 29|Percent Change From Baseline in Oxidized LDL, Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Large LDL Particles, Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Medium Small LDL Particles, Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Small LDL Particles, Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Very Small LDL Particles, Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Total LDL Particles, Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in LDL Size, The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Apolipoprotein B100, The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Percent Change From Baseline in Lipoprotein A, The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29)., Baseline and the mean of Days 28 and 29|Maximum Plasma Concentration (Cmax), Maximum PF-06291874 plasma concentration., Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|Time to Reach Cmax (Tmax), Time to maximum PF-06291874 plasma concentration., Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours), Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours., Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|Minimum Plasma Concentration (Cmin), Minimum PF-06291874 plasma concentration., Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|Apparent Clearance (CL/F), Apparent oral clearance of PF-06291874., Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
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| Sponsor/Collaborators: |
Sponsor: Pfizer
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
172
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2014-08
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| Completion Date: |
2015-03
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| Results First Posted: |
2016-06-15
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| Last Update Posted: |
2016-06-15
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| Locations: |
Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Profil Institute for Clinical Research, Inc., Chula Vista, California, 91911, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Avail Clinical Research, LLC, DeLand, Florida, 32720, United States|SeaView Research, Inc., Miami, Florida, 33125, United States|SeaView Research, Inc., Miami, Florida, 33126, United States|Compass Research, LLC, Orlando, Florida, 32806, United States|Miami Research Associates, Inc., South Miami, Florida, 33143, United States|MRA Clinical Research, LLC, South Miami, Florida, 33143, United States|MRA Clinical Research, South Miami, Florida, 33143, United States|Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, 40213, United States|DaVita Clinical Research, Minneapolis, Minnesota, 55404, United States|Clinilabs, Inc., Eatontown, New Jersey, 07724, United States|PRA International, Marlton, New Jersey, 08053, United States|Buffalo Clinical Research Center, LLC, Buffalo, New York, 14202, United States|High Point Clinical Trials Center, LLC, High Point, North Carolina, 27265, United States|Community Research, Cincinnati, Ohio, 45255, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02175121
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