Phase 1 N=84 Randomized Triple-blind Treatment

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01285518 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Number of Participants With Abnormal Physical Examination Findings

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-05231023 (Drug); Placebo (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Abnormal Physical Examination Findings	—	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	4; 3; 3; 2; 7; 2	—
PRIMARY Number of Participants With Abnormal Laboratory Values	9; 9; 9; 8; 10; 6	—
PRIMARY Number of Participants With Vital Signs Abnormalities	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Blood Glucose Abnormalities	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Anti-Drug Antibodies (ADA): Day 1	0; 1; 0; 0; 0; 0	—
PRIMARY Number of Participants With Anti-Drug Antibodies (ADA): Day 8	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Anti-Drug Antibodies (ADA): Day 15	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Anti-Drug Antibodies (ADA): Day 22	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Anti-Drug Antibodies (ADA): Day 34	—	—
PRIMARY 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	137.2; 142.3; 143.4; 146.8; 128.4; 135.7	—
PRIMARY 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	141.1; 148.0; 163.5; 152.9; 145.0; 154.9	—
PRIMARY 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	140.1; 147.5; 158.6; 164.2; 156.3; 149.8	—
PRIMARY 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	138.4; 156.1; 152.7; 155.4; 136.9; 143.6	—
PRIMARY 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	142.1; 151.0; 152.3; 157.1; 130.4; 143.9	—
PRIMARY 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	117.7; 132.6; 116.7; 131.2; 106.2; 123.2	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1	3.09; 4.03; 3.80; 3.47; 3.52; 3.44	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2	3.11; 4.04; 3.78; 3.49; 3.79; 3.53	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3	3.14; 3.99; 3.82; 3.56; 3.69; 3.38	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5	3.12; 3.98; 3.89; 3.53; 3.41; 3.27	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7	3.27; 4.01; 3.84; 3.58; 3.43; 3.25	—
PRIMARY Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15	2.88; 3.72; 3.51; 3.25; 3.11; 3.30	—
PRIMARY Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry	—	—
SECONDARY Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023	672.3; 2573; 10220; 29390; 95120; 244200	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023	0.250; 0.250; 1.50; 1.50; 1.26; 1.50	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-05231023	110.7; 347.9; 1360; 3324; 11730; 28740	—
SECONDARY Plasma Terminal Half-Life (t1/2) of PF-05231023	NA; 6.504; 7.168; 7.143; 7.748; 7.502	—
SECONDARY Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing	NA; 0.5368; 0.4642; 0.4974; 0.5245; 0.4092	—
SECONDARY Apparent Volume of Distribution (Vz) of PF-05231023	NA; 4.977; 4.741; 5.029; 5.799; 4.397	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023	NA; 2793; 10770; 30140; 95350; 244300	—
SECONDARY Back-extrapolated Concentration at Time Zero (C0) of PF-05231023	116.7; 363.0; 131.8; 415.4	—
SECONDARY Volume of Distribution at Steady State (Vss) of PF-05231023	NA; 4.897; 4.596; 5.023; 5.650; 4.082	—

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.

Eligibility Criteria

Inclusion Criteria

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%.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01285518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.