Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-60 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.
Eligibility Criteria
Inclusion
- Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
- HbA1c greater than or equal to 7% and less than or equal to 10.5%
- Total body weight \>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\^2
Exclusion
- Any condition possibly affecting drug absorption
- Diagnosis of Type 1 diabetes mellitus or secondary forms of 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
- Acute gallbladder disease
- Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
- 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
- Clinical relevant laboratory tests abnormalities
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04889157
Start Date
July 7 2021
End Date
February 17 2022
Last Update
October 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, China, 100089