Diabetes MellitusPhase 1NCT01301456

Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

A Phase 1 study testing PF-04856883 in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Pfizer at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
What is being tested?: PF-04856883
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 7 sitesUnited States
Study dates: Mar 2011to Apr 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Elite Research Institute
Miami, Florida, 33169
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Miramar, Florida, 33025
ICON Clinical Pharmacology, LLC
Omaha, Nebraska, 68154
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Healthcare Discoveries LLC d/b/a ICON Development Solutions
San Antonio, Texas, 78209

Other trials in United States

About this study

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

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.

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Being tested: Placebo, PF-04856883
Keywords: Phase 1, Type 2 Diabetes, CVX-096
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboBiological
Single subcutaneous injection of placebo
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PlaceboBiological
Single subcutaneous injection of placebo
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PF-04856883Biological
Also called CVX-096
Single subcutaneous injection of PF-04856883
PlaceboBiological
Also called CVX-096
Multiple weekly subcutaneous injections of placebo for 3 weeks
PF-04856883Biological
Also called CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883Biological
Also called CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883Biological
Also called CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883Biological
Also called CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks

Study groups in NCT01301456
Study group	Role	What they receive
Treatment Arm 1 (Stage 1A)	Placebo comparator	Not described Receives: Biological: Placebo
Treatment Arm 2 (Stage 1A)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 3 (Stage 1A)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 4 (Stage 1A)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 5 (Stage 1B)	Placebo comparator	Not described Receives: Biological: Placebo
Treatment Arm 6 (Stage 1B)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 7 (Stage 1B)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 8 (Stage 1B)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 9 (Stage 2)	Placebo comparator	Not described Receives: Biological: Placebo
Treatment Arm 10 (Stage 2)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 11 (Stage 2)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 12 (Stage 2)	Experimental	Not described Receives: Biological: PF-04856883
Treatment Arm 13 (Stage 2)	Experimental	Not described Receives: Biological: PF-04856883

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Measured: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Measured: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Measured: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
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).
Measured: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

Secondary outcomes (28)

Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Measured: 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
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Measured: 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
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 - ∞).
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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.
Measured: 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
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.
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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.
Measured: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Measured: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Measured: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Measured: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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
Measured: Baseline, Day 3 and 8
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.
Measured: Baseline, Day 3, 15, 24, 29 and 50
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.
Measured: Baseline, Day 3 and 8
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.
Measured: Baseline, Day 3, 15, 24, 29 and 50
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.
Measured: Baseline, Day 3 and 8
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.
Measured: Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Measured: Baseline, Day 2, 4, 6, 15, 22 and 29
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Measured: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
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.
Measured: Baseline, Day 30
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.
Measured: Baseline, Day 29 and 50
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Measured: Baseline, Day 8, 15 and 29
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Measured: Baseline, Day 8, 15, 22, 29 and 50
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Measured: Baseline, Day 8, 15 and 29
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Measured: Baseline, Day 8, 15, 22, 29 and 50
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Measured: Day 1 and 29
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Measured: Day 1, 29 and 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Apr 2012

First posted23 Feb 2011 (estimated)
Study startMar 2011
Primary completionDec 2011
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301456
Sponsor's protocol ID: B1111002
Status last verified: Jul 2017
First submitted: 9 Feb 2011
Last updated: 9 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01301456
Acronym / sponsor ID: B1111002
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Keywords: Phase 1, Type 2 Diabetes, CVX-096
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2011 (actual)
Primary completion: Dec 2011 (actual)
Study completion: Apr 2012 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 9 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 13

Arm	Type	Receives
Treatment Arm 1 (Stage 1A)	Placebo comparator	Biological: Placebo
Treatment Arm 2 (Stage 1A)	Experimental	Biological: PF-04856883
Treatment Arm 3 (Stage 1A)	Experimental	Biological: PF-04856883
Treatment Arm 4 (Stage 1A)	Experimental	Biological: PF-04856883
Treatment Arm 5 (Stage 1B)	Placebo comparator	Biological: Placebo
Treatment Arm 6 (Stage 1B)	Experimental	Biological: PF-04856883
Treatment Arm 7 (Stage 1B)	Experimental	Biological: PF-04856883
Treatment Arm 8 (Stage 1B)	Experimental	Biological: PF-04856883
Treatment Arm 9 (Stage 2)	Placebo comparator	Biological: Placebo
Treatment Arm 10 (Stage 2)	Experimental	Biological: PF-04856883
Treatment Arm 11 (Stage 2)	Experimental	Biological: PF-04856883
Treatment Arm 12 (Stage 2)	Experimental	Biological: PF-04856883
Treatment Arm 13 (Stage 2)	Experimental	Biological: PF-04856883

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboSingle subcutaneous injection of placebo	Biological	Treatment Arm 1 (Stage 1A)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 2 (Stage 1A)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 3 (Stage 1A)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 4 (Stage 1A)
PlaceboSingle subcutaneous injection of placebo	Biological	Treatment Arm 5 (Stage 1B)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 6 (Stage 1B)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 7 (Stage 1B)
PF-04856883Also: CVX-096Single subcutaneous injection of PF-04856883	Biological	Treatment Arm 8 (Stage 1B)
PlaceboAlso: CVX-096Multiple weekly subcutaneous injections of placebo for 3 weeks	Biological	Treatment Arm 9 (Stage 2)
PF-04856883Also: CVX-096Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks	Biological	Treatment Arm 10 (Stage 2)
PF-04856883Also: CVX-096Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks	Biological	Treatment Arm 11 (Stage 2)
PF-04856883Also: CVX-096Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks	Biological	Treatment Arm 12 (Stage 2)
PF-04856883Also: CVX-096Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks	Biological	Treatment Arm 13 (Stage 2)

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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)
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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
Time frame: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
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
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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).

28 secondary outcomes

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
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
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
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
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) 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
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
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
Apparent Clearance (CL/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
Apparent Clearance (CL/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
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
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
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
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
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
Time frame: Baseline, Day 3 and 8
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
Time frame: Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Time frame: Baseline, Day 3 and 8
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
Time frame: Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Time frame: Baseline, Day 3 and 8
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
Time frame: Baseline, Day 3, 15, 24, 29 and 50
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
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
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Time frame: Baseline, Day 30
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Time frame: Baseline, Day 29 and 50
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Time frame: Baseline, Day 8, 15 and 29
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
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Time frame: Baseline, Day 8, 15 and 29
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
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Time frame: Day 1 and 29
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Time frame: Day 1, 29 and 50

Results and safety

Results posted to the registry on 9 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1: PF-04856883 Placebo	15	15
Stage 1: PF-04856883 4 mg	5	5
Stage 1: PF-04856883 8 mg	6	5
Stage 1: PF-04856883 12 mg	6	6
Stage 1: PF-04856883 18 mg	7	6
Stage 1: PF-04856883 24 mg	5	5
Stage 1: PF-04856883 36 mg	8	7
Stage 2: Placebo	0	0
Stage 2: PF-04856883 12 mg	0	0
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg	0	0
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg	0	0
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg	0	0

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50. Number. Unit: participants

Measure	Stage 1: PF-04856883 Placebo n = 15	Stage 1: PF-04856883 4 mg n = 5	Stage 1: PF-04856883 8 mg n = 6	Stage 1: PF-04856883 12 mg n = 6	Stage 1: PF-04856883 18 mg n = 7	Stage 1: PF-04856883 24 mg n = 5	Stage 1: PF-04856883 36 mg n = 7	Stage 2: Placebo n = 7	Stage 2: PF-04856883 12 mg n = 5	Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg n = 7	Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg n = 7	Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg n = 6
SAE	0	0	0	0	0	0	0	0	0	0	0	0
AE	8	1	0	2	4	3	4	4	5	5	5	5

Population analysed: The safety population included all randomized participants who received at least 1 dose of study treatment.

Primary outcome: Number of Participants With Clinically Significant Physical Examination Findings

Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50. Number. Unit: participants

Measure	Stage 1: PF-04856883 Placebo n = 15	Stage 1: PF-04856883 4 mg n = 5	Stage 1: PF-04856883 8 mg n = 6	Stage 1: PF-04856883 12 mg n = 6	Stage 1: PF-04856883 18 mg n = 7	Stage 1: PF-04856883 24 mg n = 5	Stage 1: PF-04856883 36mg Single Dose n = 7	Stage 2: Placebo n = 7	Stage 2: PF-04856883 12 mg n = 5	Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg n = 7	Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg n = 7	Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: The safety population included all randomized participants who received at least 1 dose of study treatment.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)

Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50. Number. Unit: participants

Measure	Stage 1: PF-04856883 24 mg n = 5	Stage 1: PF-04856883 36 mg n = 7	Stage 2: Placebo n = 7	Stage 2: PF-04856883 12 mg n = 5	Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg n = 7	Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg n = 6
Maximum PR Interval IFB: >=25 or 50%	0	0	1	0	1	0
Maximum QTcB Interval IFB: 30-<60 msec	1	1	0	1	0	1
Maximum QTcF Interval IFB: 30-<60 msec	1	0	0	1	0	0

Population analysed: The safety population included all randomized participants who received at least 1 dose of study treatment.

Primary outcome: Number of Participants With Vital Sign Abnormalities

Time frame: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50. Number. Unit: participants

Measure	Stage 1: PF-04856883 Placebo n = 15	Stage 1: PF-04856883 4 mg n = 5	Stage 1: PF-04856883 8 mg n = 6	Stage 1: PF-04856883 12 mg n = 6	Stage 1: PF-04856883 18 mg n = 7	Stage 1: PF-04856883 24 mg n = 5	Stage 1: PF-04856883 36 mg n = 7	Stage 2: Placebo n = 7	Stage 2: PF-04856883 12 mg n = 5	Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg n = 7	Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg n = 7	Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg n = 6
Value	15	5	6	6	7	5	7	7	5	7	7	6

Population analysed: The safety population included all randomized participants who received at least 1 dose of study treatment.

28 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: PF-04856883 Placebo	0 of 15 (0%)	8 of 15 (53.3%)	Not reported
Stage 1: PF-04856883 4 mg	0 of 5 (0%)	1 of 5 (20%)	Not reported
Stage 1: PF-04856883 8 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Stage 1: PF-04856883 12 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Stage 1: PF-04856883 18 mg	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Stage 1: PF-04856883 24 mg	0 of 5 (0%)	3 of 5 (60%)	Not reported
Stage 1: PF-04856883 36 mg	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Stage 2: Placebo	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Stage 2: PF-04856883 12.0 mg	0 of 5 (0%)	5 of 5 (100%)	Not reported
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetes Mellitus

Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04856883 in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Pfizer at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01301456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.