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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

April 22, 2009
July 22, 2011
October 2008
June 2011   (final data collection date for primary outcome measure)
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 ]
To evaluate the safety and tolerability of single, escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00886821 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To characterize the pharmacokinetics of CVX-096 in serum after administration, under fasting conditions, of single, 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 single, escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Days 0, 3, 7 ] [ Designated as safety issue: No ]
  • To evaluate the effect on mean plasma glucose (MPG) of a single dose of CVX-096 [ Time Frame: Days 0, 3, 7 ] [ Designated as safety issue: No ]
  • To assess single dose immunogenicity [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Experimental: 1
Intervention: Biological: CVX-096
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00886821
B1111001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP