4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

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NCT03538743

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Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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

- Type 2 diabetes treated with a stable dose of metformin at least 500 mg

- HbA1c value between 7.0 and 10.5%

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


- Type 1 diabetes or secondary forms of Diabetes 

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Advanced Information
Descriptive Information
Brief Title  ICMJE 4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Brief Summary This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Placebo
    Tablet, 0 mg, twice daily, 28 days
  • Drug: PF-06882961
    Tablet, 15 mg twice daily, 28 days
  • Drug: PF-06882961
    Tablet, 50 mg twice daily, 28 days
  • Drug: PF-06882961
    Tablet, 150 mg twice daily, 28 days
  • Drug: PF-06882961
    Tablet, 300 mg twice daily, 28 days
  • Drug: PF-06882961
    Tablet, dose TBD, twice daily, Cohort 5, 28 days
  • Drug: PF-06882961
    Tablet, dose TBD, twice daily, Cohort 6, 28 days
  • Drug: PF-06882961
    Tablet, dose TBD, twice daily, Cohort 7, 28 days
  • Drug: PF-06882961
    Tablet, dose TBD, twice daily, Cohort 8, 28 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06882961 30 mg
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 100 mg
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 300 mg
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 600 mg
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 dose TBD Cohort 5
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 dose TBD Cohort 6
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 dose TBD Cohort 7
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 dose TBD Cohort 8
    Intervention: Drug: PF-06882961
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: June 6, 2019)		98
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)		96
Actual Study Completion Date  ICMJE June 10, 2019
Actual Primary Completion Date May 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes treated with a stable dose of metformin at least 500 mg
  • HbA1c value between 7.0 and 10.5%

Exclusion Criteria:

- Type 1 diabetes or secondary forms of diabetes

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 NCT03538743
Other Study ID Numbers  ICMJE C3421002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
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 June 2020

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