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

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NCT01298518

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Study Location
Pfizer Investigational Site
Chula Vista, California, 91911, United States
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Contact
1-800-718-1021
[email protected]
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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 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 <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
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;

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Type 2 Diabetes PatientsA Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients NCT01298518
  1. Chula Vista, California
  2. DeLand, Florida
  3. Miami Gardens, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Patients
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PF-04620110
    Interventions:
    • Drug: PF-04620110
    • Drug: PF-04620110
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
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: February 16, 2011)		48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01298518
Other Study ID Numbers  ICMJE B0961007
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 October 2012

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