Clinical trial NCT01301456: Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Keywords: Phase 1
Type 2 Diabetes
CVX-096
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
timeFrame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
timeFrame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
timeFrame: 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
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
timeFrame: 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
measure: Apparent Clearance (CL/F) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Apparent Clearance (CL/F) of PF-04856883: Stage 2
timeFrame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
measure: Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
timeFrame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
measure: Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
timeFrame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
measure: Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
timeFrame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
measure: 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
timeFrame: Baseline, Day 3 and 8
measure: 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
timeFrame: Baseline, Day 3, 15, 24, 29 and 50
measure: Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
timeFrame: Baseline, Day 3 and 8
measure: 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
timeFrame: Baseline, Day 3, 15, 24, 29 and 50
measure: Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
timeFrame: Baseline, Day 3 and 8
measure: 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
timeFrame: Baseline, Day 3, 15, 24, 29 and 50
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
timeFrame: Baseline, Day 2, 4, 6, 15, 22 and 29
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
timeFrame: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
measure: Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
timeFrame: Baseline, Day 30
measure: Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
timeFrame: Baseline, Day 29 and 50
measure: Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
timeFrame: Baseline, Day 8, 15 and 29
measure: Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
timeFrame: Baseline, Day 8, 15, 22, 29 and 50
measure: Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
timeFrame: Baseline, Day 8, 15 and 29
measure: Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
timeFrame: Baseline, Day 8, 15, 22, 29 and 50
measure: Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
timeFrame: Day 1 and 29
measure: Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
timeFrame: Day 1, 29 and 50
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Miramar
country: United States
facility: Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Omaha
country: United States
facility: ICON Clinical Pharmacology, LLC
state: Nebraska
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: San Antonio
country: United States
facility: Healthcare Discoveries LLC d/b/a ICON Development Solutions
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: