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

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NCT00886821

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Cetero Research
Miami Gardens, Florida, 33169 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

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

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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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00886821
B1111001
CVX-096-101 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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