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

NCT00886821

Last updated date
Study Location
Cetero Research
Miami Gardens, Florida, 33169, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Study Arms  ICMJE Experimental: 1
Intervention: Biological: CVX-096
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)
114
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2009)
48
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00886821
Other Study ID Numbers  ICMJE B1111001
CVX-096-101 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

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