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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01301456
First received: February 9, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Biological: Placebo
Biological: PF-04856883
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ] [ Designated as safety issue: Yes ]
  • Number of participants with abnormal physical examinations (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ] [ Designated as safety issue: Yes ]
  • Number of participants with abnormal 12-lead electrocardiograms (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ] [ Designated as safety issue: Yes ]
  • Number of participants with abnormal vital signs (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ] [ Designated as safety issue: Yes ]
  • Number of participants with abnormal safety laboratory measurements (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve extrapolated to tau (AUC0-tau) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Clearance (CL/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Clearance (CL/F) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Volume of distribution (Vz/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Volume of distribution (Vz/F) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t1/2) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t1/2) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Change in postprandial glucose area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ] [ Designated as safety issue: No ]
  • Change in postprandial glucose area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Change in insulin area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ] [ Designated as safety issue: No ]
  • Change in insulin area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Change in C-peptide area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ] [ Designated as safety issue: No ]
  • Change in C-peptide area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (Stage 1) [ Time Frame: Baseline, Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (Stage 2) [ Time Frame: Baseline, Days 1, 2, 3, 4, 6, 8, 15, 22, 23, 24, 25, 27, 28, 29, 30, 36, 43, 50 ] [ Designated as safety issue: No ]
  • Change in 24 hour glucose profile (Stage 2) [ Time Frame: Baseline, Day 29 ] [ Designated as safety issue: No ]
  • Change in hemoglobin A1c (Stage 2) [ Time Frame: Baseline, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Change in fructosamine (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ] [ Designated as safety issue: No ]
  • Change in fructosamine (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Change in 1,5-anhydroglucitol (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ] [ Designated as safety issue: No ]
  • Change in 1,5-anhydroglucitol (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ] [ Designated as safety issue: No ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 1) [ Time Frame: Baseline up to Day 29 ] [ Designated as safety issue: Yes ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 2) [ Time Frame: Baseline up to Day 50 ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment Arm 1 (Stage 1A) Biological: Placebo
Single subcutaneous injection of placebo
Experimental: Treatment Arm 2 (Stage 1A) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Experimental: Treatment Arm 3 (Stage 1A) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Experimental: Treatment Arm 4 (Stage 1A) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Placebo Comparator: Treatment Arm 5 (Stage 1B) Biological: Placebo
Single subcutaneous injection of placebo
Experimental: Treatment Arm 6 (Stage 1B) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Experimental: Treatment Arm 7 (Stage 1B) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Experimental: Treatment Arm 8 (Stage 1B) Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Name: CVX-096
Placebo Comparator: Treatment Arm 9 (Stage 2) Biological: Placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Other Name: CVX-096
Experimental: Treatment Arm 10 (Stage 2) Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Name: CVX-096
Experimental: Treatment Arm 11 (Stage 2) Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Name: CVX-096
Experimental: Treatment Arm 12 (Stage 2) Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Name: CVX-096
Experimental: Treatment Arm 13 (Stage 2) Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Name: CVX-096

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301456

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Miramar, Florida, United States, 33025
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68154
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01301456     History of Changes
Other Study ID Numbers: B1111002
Study First Received: February 9, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Type 2 Diabetes
CVX-096

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Metabolic Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 24, 2014