Completed
PHASE1
INTERVENTIONAL
NCT01285518
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
PF-05231023
Type:
DRUG
Description:
0.5 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
1.5 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
5 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
15 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
50 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
100 mg QD IV x 1 day
Name:
PF-05231023
Type:
DRUG
Description:
200 mg QD IV x 1 day
Name:
Placebo
Type:
OTHER
Description:
0.9% w/v sodium chloride injection, USP QD IVx 1 day
Primary Outcomes
Measure:
Number of Participants With Abnormal Physical Examination Findings
TimeFrame:
Day -1 up to Day 22
Description:
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.
Measure:
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
TimeFrame:
Day 1 up to Day 22
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 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measure:
Number of Participants With Abnormal Laboratory Values
TimeFrame:
Day -1 up to Day 15
Description:
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.
Measure:
Number of Participants With Vital Signs Abnormalities
TimeFrame:
Day 1 up to Day 15
Description:
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.
Measure:
Number of Participants With Electrocardiogram (ECG) Abnormalities
TimeFrame:
Screening up to Day 15
Description:
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).
Measure:
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels
TimeFrame:
Day 0 up to Day 22
Description:
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).
Measure:
Number of Participants With Blood Glucose Abnormalities
TimeFrame:
Day -1 up to Day 15
Description:
Criteria for blood glucose abnormality: Blood glucose levels \<0.6\*lower limit of normal (LLN) or \>1.5\*upper limit of normal (ULN).
Measure:
Number of Participants With Anti-Drug Antibodies (ADA): Day 1
TimeFrame:
Day 1
Description:
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measure:
Number of Participants With Anti-Drug Antibodies (ADA): Day 8
TimeFrame:
Day 8
Description:
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measure:
Number of Participants With Anti-Drug Antibodies (ADA): Day 15
TimeFrame:
Day 15
Description:
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measure:
Number of Participants With Anti-Drug Antibodies (ADA): Day 22
TimeFrame:
Day 22
Description:
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measure:
Number of Participants With Anti-Drug Antibodies (ADA): Day 34
TimeFrame:
Day 34
Description:
Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.
Measure:
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
TimeFrame:
Day 1
Description:
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.
Measure:
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
TimeFrame:
Day 2
Description:
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.
Measure:
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
TimeFrame:
Day 3
Description:
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.
Measure:
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
TimeFrame:
Day 5
Description:
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.
Measure:
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
TimeFrame:
Day 7
Description:
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.
Measure:
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
TimeFrame:
Day 15
Description:
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.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1
TimeFrame:
Day 1
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2
TimeFrame:
Day 2
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3
TimeFrame:
Day 3
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5
TimeFrame:
Day 5
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7
TimeFrame:
Day 7
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15
TimeFrame:
Day 15
Description:
Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.
Measure:
Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry
TimeFrame:
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
Description:
Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.
Trial Information
NCT ID
NCT01285518
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Pfizer
Last Updated
December 15, 2025