A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
NCT ID: NCT04552470
Last Updated: 2022-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2020-10-26
2021-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo
Placebo
3 matching placebo tablets taken twice a day (BID)
PF-06882961 40 mg
Participants will be titrated up to 2 weeks to reach desired dose level
PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
PF-06882961 80 mg
Participants will be titrated up to 4 weeks to reach desired dose level
PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
PF-06882961 120 mg
Participants will be titrated up to 6 weeks to reach desired dose level
PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
Interventions
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Placebo
3 matching placebo tablets taken twice a day (BID)
PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* HbA1c greater than or equal to 7% and less than or equal to 10.5%
* Total body weight \>50 kg (110 lb) with BMI 22.5 to 45.4 kg/m\^2
Exclusion Criteria
* Diagnosis of Type 1 diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
* Any malignancy not considered cured
* Personal or family history of MTC or MEN2, or participants with suspected MTC
* Acute pancreatitis or history of chronic pancreatitis
* Symptomatic gallbladder disease
* Known medical history of active proliferative retinopathy and/or macular edema
* Known history of HIV, hepatitis B, hepatitis C or syphilis
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug test
20 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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P-one clinic, Keikokai medical corporation
Hachiōji, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3421015
Identifier Type: -
Identifier Source: org_study_id
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