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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301456
First Posted: February 23, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Number of participants with abnormal physical examinations (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • 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 ]
  • Number of participants with abnormal vital signs (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Clearance (CL/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • 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 ]
  • Volume of distribution (Vz/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • 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 ]
  • Terminal elimination half-life (t1/2) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in insulin area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in fasting plasma glucose (Stage 1) [ Time Frame: Baseline, Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • 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 ]
  • Change in 24 hour glucose profile (Stage 2) [ Time Frame: Baseline, Day 29 ]
  • Change in hemoglobin A1c (Stage 2) [ Time Frame: Baseline, Day 29, Day 50 ]
  • Change in fructosamine (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ]
  • Change in fructosamine (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ]
  • Change in 1,5-anhydroglucitol (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ]
  • Change in 1,5-anhydroglucitol (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 1) [ Time Frame: Baseline up to Day 29 ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 2) [ Time Frame: Baseline up to Day 50 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01301456     History of Changes
Other Study ID Numbers: B1111002
First Submitted: February 9, 2011
First Posted: February 23, 2011
Last Update Posted: October 12, 2017
Last Verified: May 2012

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

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