Diabetes Mellitus, Type 2Phase 1NCT01285518

Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

A Phase 1 study testing PF-05231023 in people with Diabetes Mellitus, Type 2, run by Pfizer at 5 sites in United States.

Completed

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

Official record

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Trial summary

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: PF-05231023
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 5 sitesUnited States
Study dates: Feb 2011to Jul 2011
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 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
HbA1c >7% and not to exceed 10.5%.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Diagnosis of Type 1 diabetes mellitus
Evidence of diabetic complications with significant end organ damage.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Fort Meyers, Florida, 33901
Elite Research Institute
Miami, Florida, 33169
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Miramar, Florida, 33025
Cetero Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of Pf-05231023 In Adult Subjects With Type 2 Diabetes

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.

Conditions: Diabetes Mellitus, Type 2
Being tested: PF-05231023, Placebo
Keywords: Type 2 diabetes, intravenous, single dose
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

PF-05231023Drug
0.5 mg QD IV x 1 day
PF-05231023Drug
1.5 mg QD IV x 1 day
PF-05231023Drug
5 mg QD IV x 1 day
PF-05231023Drug
15 mg QD IV x 1 day
PF-05231023Drug
50 mg QD IV x 1 day
PF-05231023Drug
100 mg QD IV x 1 day
PF-05231023Drug
200 mg QD IV x 1 day
PlaceboOther
0.9% w/v sodium chloride injection, USP QD IVx 1 day

Study groups in NCT01285518
Study group	Role	What they receive
Treatment	Experimental	Not described Receives: Drug: PF-05231023
Placebo	Placebo comparator	0.9% w/v sodium chloride injection, USP Receives: Other: Placebo

What is being measured

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

Number of Participants With Abnormal Physical Examination Findings
Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.
Measured: Day -1 up to Day 22
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 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Day 1 up to Day 22
Number of Participants With Abnormal Laboratory Values
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.
Measured: Day -1 up to Day 15
Number of Participants With Vital Signs Abnormalities
Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
Measured: Day 1 up to Day 15
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
Measured: Screening up to Day 15
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels
Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).
Measured: Day 0 up to Day 22
Number of Participants With Blood Glucose Abnormalities
Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).
Measured: Day -1 up to Day 15
Number of Participants With Anti-Drug Antibodies (ADA): Day 1
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measured: Day 1
Number of Participants With Anti-Drug Antibodies (ADA): Day 8
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measured: Day 8
Number of Participants With Anti-Drug Antibodies (ADA): Day 15
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measured: Day 15
Number of Participants With Anti-Drug Antibodies (ADA): Day 22
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measured: Day 22
Number of Participants With Anti-Drug Antibodies (ADA): Day 34
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measured: Day 34
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.
Measured: Day 1
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Measured: Day 2
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Measured: Day 3
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Measured: Day 5
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Measured: Day 7
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Measured: Day 15
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 1
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 2
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 3
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 5
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 7
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measured: Day 15
Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry
Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.
Measured: From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1

Secondary outcomes (9)

Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023
Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Maximum Observed Plasma Concentration (Cmax) of PF-05231023
Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Plasma Terminal Half-Life (t1/2) of PF-05231023
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.
Measured: Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Apparent Volume of Distribution (Vz) of PF-05231023
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023
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 - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Back-extrapolated Concentration at Time Zero (C0) of PF-05231023
C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.
Measured: 0.25 H post-dose to Bo on Day 1
Volume of Distribution at Steady State (Vss) of PF-05231023
Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.
Measured: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Timeline

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

Feb 2011Jul 2011

First posted28 Jan 2011 (estimated)
Study startFeb 2011
Primary completionJul 2011
Study completionJul 2011

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 Mellitus, Type 2Studies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01285518
Sponsor's protocol ID: B2901001
Status last verified: Sep 2016
First submitted: 26 Jan 2011
Last updated: 18 Nov 2016
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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of Pf-05231023 In Adult Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01285518
Acronym / sponsor ID: B2901001
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes, intravenous, single dose
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 28 Jan 2011 (estimated)
Results: Posted 18 Nov 2016

Clinical summary

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

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Drug: PF-05231023
Placebo	Placebo comparator	Other: Placebo0.9% w/v sodium chloride injection, USP

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
HbA1c >7% and not to exceed 10.5%.

Key exclusion criteria (3 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Diagnosis of Type 1 diabetes mellitus
Evidence of diabetic complications with significant end organ damage.

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
PF-052310230.5 mg QD IV x 1 day	Drug	Treatment
PF-052310231.5 mg QD IV x 1 day	Drug	Treatment
PF-052310235 mg QD IV x 1 day	Drug	Treatment
PF-0523102315 mg QD IV x 1 day	Drug	Treatment
PF-0523102350 mg QD IV x 1 day	Drug	Treatment
PF-05231023100 mg QD IV x 1 day	Drug	Treatment
PF-05231023200 mg QD IV x 1 day	Drug	Treatment
Placebo0.9% w/v sodium chloride injection, USP QD IVx 1 day	Other	Placebo

Primary outcome

Number of Participants With Abnormal Physical Examination Findings
Time frame: Day -1 up to Day 22
Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 22
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 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Abnormal Laboratory Values
Time frame: Day -1 up to Day 15
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.
Number of Participants With Vital Signs Abnormalities
Time frame: Day 1 up to Day 15
Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Screening up to Day 15
Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels
Time frame: Day 0 up to Day 22
Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).
Number of Participants With Blood Glucose Abnormalities
Time frame: Day -1 up to Day 15
Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).
Number of Participants With Anti-Drug Antibodies (ADA): Day 1
Time frame: Day 1
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Number of Participants With Anti-Drug Antibodies (ADA): Day 8
Time frame: Day 8
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Number of Participants With Anti-Drug Antibodies (ADA): Day 15
Time frame: Day 15
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Number of Participants With Anti-Drug Antibodies (ADA): Day 22
Time frame: Day 22
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Number of Participants With Anti-Drug Antibodies (ADA): Day 34
Time frame: Day 34
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1
Time frame: Day 1
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2
Time frame: Day 2
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3
Time frame: Day 3
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5
Time frame: Day 5
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7
Time frame: Day 7
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15
Time frame: Day 15
Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1
Time frame: Day 1
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2
Time frame: Day 2
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3
Time frame: Day 3
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5
Time frame: Day 5
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7
Time frame: Day 7
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15
Time frame: Day 15
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry
Time frame: From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1
Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.

9 secondary outcomes

Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Maximum Observed Plasma Concentration (Cmax) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Plasma Terminal Half-Life (t1/2) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing
Time frame: Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Apparent Volume of Distribution (Vz) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Back-extrapolated Concentration at Time Zero (C0) of PF-05231023
Time frame: 0.25 H post-dose to Bo on Day 1
Volume of Distribution at Steady State (Vss) of PF-05231023
Time frame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Results and safety

Results posted to the registry on 18 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-05231023 0.5 mg	10	10
PF-05231023 1.5 mg	10	10
PF-05231023 5 mg	10	10
PF-05231023 15 mg	10	10
PF-05231023 50 mg	10	10
PF-05231023 100 mg	10	9
PF-05231023 200 mg	10	10
Placebo	14	14

Primary outcome: Number of Participants With Abnormal Physical Examination Findings

Time frame: Day -1 up to Day 22

Population analysed: Data was not collected since this outcome measure was not analyzed as per Sponsor's discretion.

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

Time frame: Day 1 up to Day 22. Number. Unit: participants

Measure	PF-05231023 0.5 mg n = 10	PF-05231023 1.5 mg n = 10	PF-05231023 5 mg n = 10	PF-05231023 15 mg n = 10	PF-05231023 50 mg n = 10	PF-05231023 100 mg n = 10	PF-05231023 200 mg n = 10	Placebo n = 14
AEs	4	3	3	2	7	2	8	5
SAEs	0	0	0	0	0	0	0	0

Population analysed: Safety population included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Abnormal Laboratory Values

Time frame: Day -1 up to Day 15. Number. Unit: participants

Measure	PF-05231023 0.5 mg n = 10	PF-05231023 1.5 mg n = 10	PF-05231023 5 mg n = 10	PF-05231023 15 mg n = 10	PF-05231023 50 mg n = 10	PF-05231023 100 mg n = 10	PF-05231023 200 mg n = 10	Placebo n = 14
Value	9	9	9	8	10	6	6	14

Population analysed: Safety population included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Vital Signs Abnormalities

Time frame: Day 1 up to Day 15. Number. Unit: participants

Measure	PF-05231023 0.5 mg n = 10	PF-05231023 1.5 mg n = 10	PF-05231023 5 mg n = 10	PF-05231023 15 mg n = 10	PF-05231023 50 mg n = 10	PF-05231023 100 mg n = 10	PF-05231023 200 mg n = 10	Placebo n = 14
Supine SBP <90 mmHg	0	0	0	0	0	0	0	1
Supine DBP <50 mmHg	1	0	0	0	0	0	0	0
Supine pulse rate <40 bpm	0	0	0	0	0	0	0	0
Supine pulse rate >120 bpm	0	0	0	0	0	0	0	1
Supine SBP: Maximum increase >=30 mmHg	2	1	0	0	0	1	2	0
Supine DBP: Maximum increase >=20 mmHg	0	0	0	0	0	1	0	0
Supine SBP: Maximum decrease >=30 mmHg	1	0	0	2	1	2	0	1
Supine DBP: Maximum decrease >=20 mmHg	0	0	2	0	1	1	0	1

Population analysed: Safety population included all participants who received at least 1 dose of study medication.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-05231023 0.5 mg	0 of 10 (0%)	4 of 10 (40%)	Not reported
PF-05231023 1.5 mg	0 of 10 (0%)	3 of 10 (30%)	Not reported
PF-05231023 5 mg	0 of 10 (0%)	3 of 10 (30%)	Not reported
PF-05231023 15 mg	0 of 10 (0%)	2 of 10 (20%)	Not reported
PF-05231023 50 mg	0 of 10 (0%)	7 of 10 (70%)	Not reported
PF-05231023 100 mg	0 of 10 (0%)	2 of 10 (20%)	Not reported
PF-05231023 200 mg	0 of 10 (0%)	8 of 10 (80%)	Not reported
Placebo	0 of 14 (0%)	5 of 14 (35.7%)	Not reported

Limitations and caveats (from the sponsor): Results for C0 and Vss was included as secondary endpoints as per change in the planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
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.

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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

5 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-05231023 in people with Diabetes Mellitus, Type 2, run by Pfizer at 5 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 3 inclusion and 3 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 18 Nov 2016). 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 Abnormal Physical Examination Findings (time frame: Day -1 up to Day 22). The study lists 25 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 NCT01285518.

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 18 Nov 2016.