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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 22, 2009
Last updated: July 30, 2015
Last verified: July 2015
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
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

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 ]

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 ]
  • 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 ]
  • To evaluate the effect on mean plasma glucose (MPG) after receiving doses of CVX-096 [ Time Frame: Throughout duration of study ]
  • To assess immunogenicity [ Time Frame: Throughout duration of study ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 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 Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00886821     History of Changes
Other Study ID Numbers: B1111001
Study First Received: April 22, 2009
Last Updated: July 30, 2015

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 processed this record on March 24, 2017