A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889157
• Other study ID #: C3421028
• Status: Completed
• Phase: Phase 1
• Start date: July 7, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• PF-06882961
Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
• Placebo
3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve		0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56
Primary	Maximum observed plasma concentration		0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56
Secondary	Number of participants with clinically significant change from baseline in vital signs		Baseline up to 14 days after last dose (Day 70)
Secondary	Number of participants with abnormal Electrocardiogram (ECG)		Baseline up to 14 days after last dose (Day 70)
Secondary	Number of participants with treatment emergent treatment-related adverse events		Baseline up to 35 days after last dose (Day 91)
Secondary	Number of participants with laboratory abnormalities		Baseline up to 14 days after last dose (Day 70)

External Links

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