Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
PF-04856883
PF-04856883
PF-04856883
Placebo
PF-04856883
PF-04856883
PF-04856883
Placebo
PF-04856883
PF-04856883
PF-04856883
PF-04856883
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Phase 1, Type 2 Diabetes, CVX-096
Eligibility Criteria
Inclusion Criteria:
- History of Type 2 diabetes and currently being treated with high dose metformin
- BMI between 22.0 and 40.0 kg/m2
- HbA1c between 7.0-10.0%
- Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
- History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
- Treatment with anti-diabetic therapies other than metformin
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- Males or women of childbearing potential
Sites / Locations
- Profil Institute for Clinical Research, Inc.
- Elite Research Institute
- Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
- Atlanta Center for Medical Research
- ICON Clinical Pharmacology, LLC
- CRI Worldwide, LLC
- Healthcare Discoveries LLC d/b/a ICON Development Solutions
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment Arm 1 (Stage 1A)
Treatment Arm 2 (Stage 1A)
Treatment Arm 3 (Stage 1A)
Treatment Arm 4 (Stage 1A)
Treatment Arm 5 (Stage 1B)
Treatment Arm 6 (Stage 1B)
Treatment Arm 7 (Stage 1B)
Treatment Arm 8 (Stage 1B)
Treatment Arm 9 (Stage 2)
Treatment Arm 10 (Stage 2)
Treatment Arm 11 (Stage 2)
Treatment Arm 12 (Stage 2)
Treatment Arm 13 (Stage 2)
Arm Description
Outcomes
Primary Outcome Measures
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 drug 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 drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Clinically Significant Physical Examination Findings
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
Number of Participants With Vital Sign Abnormalities
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
Apparent Clearance (CL/F) of PF-04856883: Stage 1
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
Apparent Clearance (CL/F) of PF-04856883: Stage 2
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
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
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
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.
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
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.
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
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.
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01301456
Brief Title
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Official Title
A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Keywords
Phase 1, Type 2 Diabetes, CVX-096
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm 1 (Stage 1A)
Arm Type
Placebo Comparator
Arm Title
Treatment Arm 2 (Stage 1A)
Arm Type
Experimental
Arm Title
Treatment Arm 3 (Stage 1A)
Arm Type
Experimental
Arm Title
Treatment Arm 4 (Stage 1A)
Arm Type
Experimental
Arm Title
Treatment Arm 5 (Stage 1B)
Arm Type
Placebo Comparator
Arm Title
Treatment Arm 6 (Stage 1B)
Arm Type
Experimental
Arm Title
Treatment Arm 7 (Stage 1B)
Arm Type
Experimental
Arm Title
Treatment Arm 8 (Stage 1B)
Arm Type
Experimental
Arm Title
Treatment Arm 9 (Stage 2)
Arm Type
Placebo Comparator
Arm Title
Treatment Arm 10 (Stage 2)
Arm Type
Experimental
Arm Title
Treatment Arm 11 (Stage 2)
Arm Type
Experimental
Arm Title
Treatment Arm 12 (Stage 2)
Arm Type
Experimental
Arm Title
Treatment Arm 13 (Stage 2)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single subcutaneous injection of placebo
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single subcutaneous injection of placebo
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Single subcutaneous injection of PF-04856883
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
CVX-096
Intervention Description
Multiple weekly subcutaneous injections of placebo for 3 weeks
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Intervention Type
Biological
Intervention Name(s)
PF-04856883
Other Intervention Name(s)
CVX-096
Intervention Description
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug 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 drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Title
Number of Participants With Clinically Significant Physical Examination Findings
Description
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
Time Frame
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Title
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Description
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
Time Frame
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Title
Number of Participants With Vital Sign Abnormalities
Description
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
Time Frame
Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
Title
Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Description
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
Time Frame
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
Description
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Description
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
Title
Apparent Clearance (CL/F) of PF-04856883: Stage 1
Description
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Apparent Clearance (CL/F) of PF-04856883: Stage 2
Description
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
Time Frame
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Title
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Time Frame
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Title
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Time Frame
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Title
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Time Frame
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Title
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Description
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
Time Frame
Baseline, Day 3 and 8
Title
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Description
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.
Time Frame
Baseline, Day 3, 15, 24, 29 and 50
Title
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Description
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time Frame
Baseline, Day 3 and 8
Title
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Description
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time Frame
Baseline, Day 3, 15, 24, 29 and 50
Title
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Description
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.
Time Frame
Baseline, Day 3 and 8
Title
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Description
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.
Time Frame
Baseline, Day 3, 15, 24, 29 and 50
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Time Frame
Baseline, Day 2, 4, 6, 15, 22 and 29
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Time Frame
Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
Title
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Description
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
Time Frame
Baseline, Day 30
Title
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Description
HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
Time Frame
Baseline, Day 29 and 50
Title
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Time Frame
Baseline, Day 8, 15 and 29
Title
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Time Frame
Baseline, Day 8, 15, 22, 29 and 50
Title
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Time Frame
Baseline, Day 8, 15 and 29
Title
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Time Frame
Baseline, Day 8, 15, 22, 29 and 50
Title
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Time Frame
Day 1 and 29
Title
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Time Frame
Day 1, 29 and 50
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of Type 2 diabetes and currently being treated with high dose metformin
BMI between 22.0 and 40.0 kg/m2
HbA1c between 7.0-10.0%
Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
Treatment with anti-diabetic therapies other than metformin
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
Males or women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute for Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Elite Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
ICON Clinical Pharmacology, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Healthcare Discoveries LLC d/b/a ICON Development Solutions
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1111002&StudyName=Single-Dose%20And%20Multiple-Dose%20Safety%20And%20Tolerability%20Study%20Of%20PF-04856883%20In%20Type%202%20Diabetic%20Adult%20Females%20
Description
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Learn more about this trial
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
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