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

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NCT03538743

Last updated on November 1, 2018
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FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 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

- 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 

NCT03538743
Pfizer
Recruiting
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
96
Same as current
February 24, 2019
February 24, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03538743
C3421002
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2018

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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