Back to resultsA Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PF-06882961
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PF-06882961
Placebo
Arm Description
Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg
Placebo
Outcomes
Primary Outcome Measures
Area under the concentration-time curve
Maximum observed plasma concentration
Secondary Outcome Measures
Number of participants with clinically significant change from baseline in vital signs
Number of participants with abnormal Electrocardiogram (ECG)
Number of participants with treatment emergent treatment-related adverse events
Number of participants with laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889157
Brief Title
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Official Title
AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-06882961
Arm Type
Experimental
Arm Description
Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-06882961
Intervention Description
Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
Primary Outcome Measure Information:
Title
Area under the concentration-time curve
Time Frame
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56
Title
Maximum observed plasma concentration
Time Frame
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56
Secondary Outcome Measure Information:
Title
Number of participants with clinically significant change from baseline in vital signs
Time Frame
Baseline up to 14 days after last dose (Day 70)
Title
Number of participants with abnormal Electrocardiogram (ECG)
Time Frame
Baseline up to 14 days after last dose (Day 70)
Title
Number of participants with treatment emergent treatment-related adverse events
Time Frame
Baseline up to 35 days after last dose (Day 91)
Title
Number of participants with laboratory abnormalities
Time Frame
Baseline up to 14 days after last dose (Day 70)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100089
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3421028
Description
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Learn more about this trial
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
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