4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
NCT03538743
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
18-70 years
Inclusion Criteria
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
Show details
- Type 1 diabetes or secondary forms of Diabetes
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Advanced Information
Descriptive Information | |||||
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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 |
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Study Arms ICMJE |
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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 | 98 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria: - Type 1 diabetes or secondary forms of diabetes | ||||
Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |