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Trial record 1 of 1 for:    C3421015
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552470
Recruitment Status : Completed
First Posted : September 17, 2020
Results First Posted : March 11, 2022
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Type 2 Diabetes Mellitus
Interventions Drug: Placebo
Drug: PF-06882961
Enrollment 37
Recruitment Details  
Pre-assignment Details 65 participants signed the inform consent form (ICF). 28 participants were screen failures who did not meet criteria and were not enrolled. 37 participants enrolled into the study and assigned to a study treatment.
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description Participants with type 2 diabetes mellitus (T2DM) were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Period Title: Overall Study
Started 9 10 9 9
Completed 9 10 9 9
Not Completed 0 0 0 0
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg Total
Hide Arm/Group Description Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 9 10 9 9 37
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 9 participants 9 participants 37 participants
58.6  (8.75) 55.9  (10.04) 58.0  (6.69) 50.7  (7.50) 55.8  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 9 participants 37 participants
Female
1
  11.1%
2
  20.0%
1
  11.1%
1
  11.1%
5
  13.5%
Male
8
  88.9%
8
  80.0%
8
  88.9%
8
  88.9%
32
  86.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 9 participants 37 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
9
 100.0%
10
 100.0%
9
 100.0%
9
 100.0%
37
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 9 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
9
 100.0%
10
 100.0%
9
 100.0%
9
 100.0%
37
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Time Frame Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 9 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
3
  33.3%
7
  70.0%
9
 100.0%
9
 100.0%
Participants with SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities
Hide Description Leukocytes (10^9/liter [L]) bilirubin (micromol/L), glucose (millimoles [mmol]/L), triacylglycerol lipase (microkatals [microkat]/L): greater than (>) 1.5*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits [mU]/L): less than (<) 0.8*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): >1.2*ULN; triglycerides: >1.3*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): >3.0*ULN; cholesterol (mmol/L): >1.3*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (>=) 1; granular casts, hyaline casts: >1.
Time Frame Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 9 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
10
 100.0%
8
  88.9%
9
 100.0%
3.Primary Outcome
Title Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline
Hide Description Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP <90 mmHg, maximum of SBP >=30 mmHg decrease from baseline and maximum of SBP >=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP <50 mmHg, maximum of DBP >20 mmHg decrease from baseline and maximum of DBP >=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate <40 BPM and maximum of absolute supine pulse rate >120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.
Time Frame Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 9 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Minimum of absolute SBP <90 mmHg
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum of SBP >=30 mmHg decrease
1
  11.1%
0
   0.0%
0
   0.0%
1
  11.1%
Maximum of SBP >=30 mmHg increase
3
  33.3%
2
  20.0%
3
  33.3%
2
  22.2%
Minimum of absolute DBP <50 mmHg
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum of DBP >=20 mmHg decrease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum of DBP >=20 mmHg increase
1
  11.1%
2
  20.0%
3
  33.3%
3
  33.3%
Minimum of absolute pulse rate <40 BPM
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum of absolute pulse rate >120 BPM
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline
Hide Description PR interval had following categories: maximum absolute PR interval >=300 milliseconds (msec); when baseline PR interval >200 msec and maximum increase from baseline in PR interval >=25 percent; when baseline PR interval less than or equal to (<=) 200 msec and maximum increase from baseline in PR interval >=50 percent. QRS interval had following categories: maximum absolute QRS interval >=140 msec; maximum increase from baseline in QRS interval >=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval >450 msec to <=480 msec; absolute QTCF interval >480 msec to <=500 msec; absolute QTCF interval >500 msec; QTCF interval increase from baseline >=30 msec to <=60 msec; QTCF interval increase from baseline >60 msec.
Time Frame Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 9 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum absolute PR >=300 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline PR >200 msec and maximum increase in PR >=25%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline PR <=200 msec and maximum increase in PR >=50%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum absolute QRS >=140 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum increase in QRS >=50%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Absolute QTCF interval >450 msec to <=480 msec
1
  11.1%
0
   0.0%
1
  11.1%
1
  11.1%
Absolute QTCF interval >480 msec to <=500 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Absolute QTCF >500 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTCF increase >=30 msec to <=60 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTCF increase >60 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961
Hide Description AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports AUC24 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.
Arm/Group Title PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 10 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*hour per milliliter
Day 1 Number Analyzed 10 participants 9 participants 9 participants
414.4
(58%)
500.3
(58%)
484.5
(73%)
Day 56 Number Analyzed 7 participants 6 participants 7 participants
2424
(45%)
4691
(75%)
6953
(148%)
6.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) Observed of PF-06882961
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Cmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.
Arm/Group Title PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 10 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
Day 1 Number Analyzed 10 participants 9 participants 9 participants
32.83
(55%)
45.89
(52%)
39.35
(80%)
Day 56 Number Analyzed 7 participants 6 participants 7 participants
206.1
(54%)
352.2
(75%)
551.7
(153%)
7.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Tmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.
Arm/Group Title PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description:
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 10 9 9
Median (Full Range)
Unit of Measure: Hours
Day 1 Number Analyzed 10 participants 9 participants 9 participants
12.0
(2.00 to 23.8)
12.0
(1.00 to 12.0)
12.0
(1.00 to 14.0)
Day 56 Number Analyzed 7 participants 6 participants 7 participants
12.0
(6.00 to 13.8)
12.9
(2.00 to 36.0)
12.0
(0.000 to 13.8)
8.Secondary Outcome
Title Terminal Phase Half-Life (t1/2) of PF-06882961
Hide Description t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time Frame Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56
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Hide Analysis Population Description
PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports t1/2 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo".
Arm/Group Title PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
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Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Number of Participants Analyzed 6 3 7
Mean (Standard Deviation)
Unit of Measure: Hours
6.373  (1.7404) 5.543  (0.30827) 5.300  (0.80594)
Time Frame Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)
Adverse Event Reporting Description Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
 
Arm/Group Title Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Hide Arm/Group Description Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
All-Cause Mortality
Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/10 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
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Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/10 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo PF-06882961 40 mg PF-06882961 80 mg PF-06882961 120 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/9 (33.33%)   7/10 (70.00%)   9/9 (100.00%)   9/9 (100.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  0/9 (0.00%)  4/10 (40.00%)  4/9 (44.44%)  5/9 (55.56%) 
Abdominal pain upper * 1  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Dental caries * 1  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Diarrhoea * 1  0/9 (0.00%)  1/10 (10.00%)  2/9 (22.22%)  1/9 (11.11%) 
Nausea * 1  0/9 (0.00%)  6/10 (60.00%)  8/9 (88.89%)  4/9 (44.44%) 
Stomatitis * 1  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Vomiting * 1  0/9 (0.00%)  5/10 (50.00%)  6/9 (66.67%)  5/9 (55.56%) 
Infections and infestations         
Gastroenteritis * 1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Hordeolum * 1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Influenza * 1  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Investigations         
Alanine aminotransferase increased * 1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Aspartate aminotransferase increased * 1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Lipase increased * 1  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  1/9 (11.11%) 
Hypoglycaemia * 1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Nervous system disorders         
Headache * 1  1/9 (11.11%)  2/10 (20.00%)  1/9 (11.11%)  0/9 (0.00%) 
Presyncope * 1  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders         
Dermatitis psoriasiform * 1  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA v.23.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04552470    
Other Study ID Numbers: C3421015
First Submitted: September 11, 2020
First Posted: September 17, 2020
Results First Submitted: December 14, 2021
Results First Posted: March 11, 2022
Last Update Posted: March 11, 2022