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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

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NCT01298518

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chula Vista, California, 91911 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 Patients
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and/or female subjects between the ages of 18 and 60 years;

- Body Mass Index (BMI) of >25.0 kg/m2 and

- Subjects must have a historical diagnosis of T2DM in accordance with the ADA
guidelines;

- Subjects who have been on well-tolerated and stable doses of metformin

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

- Recent evidence (6 months prior to screening) or history of unstable major organ
disease;

- Diagnosis of Type 1 diabetes mellitus;

- Current medical history of myocardial infarction, unstable angina, or history of
stroke (including TIA) within 6 months prior to Screening;

- Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic
agents;

NCT01298518
Pfizer
Completed
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Patients
  • Drug: PF-04620110
    5 mg of PF-04620110 given once daily
  • Drug: PF-04620110
    2.5 mg of PF-04620110 given twice daily
  • Drug: Placebo
    Matching placebo giving for 4 weeks
  • Experimental: PF-04620110
    Interventions:
    • Drug: PF-04620110
    • Drug: PF-04620110
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and/or female subjects between the ages of 18 and 60 years;
  • Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
  • Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
  • Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

  • Recent evidence (6 months prior to screening) or history of unstable major organ disease;
  • Diagnosis of Type 1 diabetes mellitus;
  • Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
  • Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01298518
B0961007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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