A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00886821
First received: April 22, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: CVX-096
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of CVX-096 In Type 2 Diabetic Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of CVX-096 in serum after administration, under fasting conditions, of escalating, subcutaneous doses of CVX-096 to adult subjects with T2DM [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacodynamic effect (glucose AUC lowering) of escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Throughout duration of study ] [ Designated as safety issue: No ]
  • To evaluate the effect on mean plasma glucose (MPG) after receiving doses of CVX-096 [ Time Frame: Throughout duration of study ] [ Designated as safety issue: No ]
  • To assess immunogenicity [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 114
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
  • Hb A1c between 7-10%.
  • Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria:

  • History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
  • Patients with pancreatitis or considered a high risk for pancreatitis.
  • History of contraindications to metformin therapy.
  • Previous treatment with an approved or investigational GLP 1 mimetic.
  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: NCT00886821

Locations
United States, Florida
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00886821     History of Changes
Other Study ID Numbers: B1111001
Study First Received: April 22, 2009
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1 Type 2 diabetes CVX-096 diabetes mellitus
adult-onset diabetes mellitus
non-insulin dependent

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

ClinicalTrials.gov processed this record on October 22, 2014