Phase 1 Completed N=52 Randomized Double-blind Treatment

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

Diabetes · Type 2 Diabetes Mellitus · Glucose Metabolism Disorders · Metabolic Syndrome

Source: ClinicalTrials.gov NCT01301456 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 0; 0; 0; 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Physical Examination Findings	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Vital Sign Abnormalities	15; 5; 6; 6; 7; 5	—
PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements	15; 5; 6; 6; 7; 4	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1	181.2; 324.7; 793.7; 1855; 1776; 2006	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2	1369; 1203; 1027; 1407; 1802; 2757	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1	168; 120; 120; 120; 120; 122	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2	336; 336; 335; 336; 48.0; 72.0	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1	44920; 95190; 295200; 527100; 711300; 652000	—
SECONDARY Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2	85370; 99780; 89390; 91130; 269000; 377400	—
SECONDARY Apparent Clearance (CL/F) of PF-04856883: Stage 1	89.14; 84.08; 40.60; 34.13; 33.73; 55.32	—
SECONDARY Apparent Clearance (CL/F) of PF-04856883: Stage 2	44.67; NA; NA; NA	—
SECONDARY Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1	18760; 21710; 9191; 7127; 8437; 10010	—
SECONDARY Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2	9550; NA; NA; NA	—
SECONDARY Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1	146.3; 179.7; 147.0; 133.8; 173.7; 131.6	—
SECONDARY Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2	149.4; 135.0; 143.8; 145.0	—
SECONDARY 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	656.35; 834.03; 712.11; 796.14; 660.64; 652.20	—
SECONDARY 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	606.49; 811.36; 756.17; 800.66; 723.57; 44.41	—
SECONDARY Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1	222.18; 227.07; 210.80; 235.84; 105.34; 257.73	—
SECONDARY 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	175.26; 176.65; 267.29; 162.96; 190.64; 38.32	—
SECONDARY Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1	15.53; 16.63; 16.43; 16.80; 10.64; 16.17	—
SECONDARY 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	13.47; 14.59; 15.63; 11.74; 14.14; 1.68	—
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1	161.67; 219.60; 171.17; 174.00; 168.57; 145.60	—
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2	148.00; 186.80; 191.14; 187.29; 158.50; 3.00	—
SECONDARY Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2	166.19; 212.43; 205.56; 202.43; 186.13; 172.36	0.219
SECONDARY Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2	0.06; -0.24; -0.41; -0.42; -0.40; 0.15	0.419
SECONDARY Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1	270.60; 289.20; 279.67; 304.83; 263.43; 259.80	—
SECONDARY Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2	281.14; 309.40; 301.14; 291.29; 303.67; -5.29	0.663
SECONDARY Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1	8.17; 5.02; 5.77; 5.35; 6.20; 12.04	—
SECONDARY Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2	7.66; 6.32; 8.09; 7.59; 3.95; -0.10	0.387
SECONDARY Number of Participants With Anti-Drug Antibodies (ADA): Stage 1	1; 1; 0; 0; 0; 2	—
SECONDARY Number of Participant With Anti-Drug Antibodies (ADA): Stage 2	0; 1; 1; 0; 0; 2	—

Eligibility Criteria

Inclusion Criteria

History of Type 2 diabetes and currently being treated with high dose metformin
BMI between 22.0 and 40.0 kg/m2
HbA1c between 7.0-10.0%
Fasting C-peptide >1.21 ng/mL

Exclusion Criteria

History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
Treatment with anti-diabetic therapies other than metformin
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
Males or women of childbearing potential

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01301456). 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. Informational only — not medical advice.