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

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

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


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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886821

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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014