| 4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
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| 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
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| 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.
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| Not Provided
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| Interventional
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| Phase 1
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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| Type 2 Diabetes Mellitus
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- 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
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- 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
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| Not Provided
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| |
| Completed
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| 98
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| 96
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| June 10, 2019
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| May 23, 2019 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: |
All |
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| 18 Years to 70 Years (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| United States
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| NCT03538743
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| C3421002
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| No
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| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
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| 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/da.... |
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| June 2019
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