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.
- Type 2 diabetes treated with a stable dose of metformin at least 500 mg
- HbA1c value between 7.0 and 10.5%
- Type 1 diabetes or secondary forms of diabetes
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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: Parallel 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 2019 | ||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
