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

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Cetero Research
Miami Gardens, Florida, 33169 United States
Contact
1-800-718-1021
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.
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- 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.

NCT00886821
Pfizer
Completed
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

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[email protected]

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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 SummaryThe purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Detailed DescriptionNot 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 DateJune 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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