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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: PF-06882961
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06882961<br>Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg | Drug: PF-06882961<br>* Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maximum observed plasma concentration |  | 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinically significant change from baseline in vital signs |  | Baseline up to 14 days after last dose (Day 70) | 
| Number of participants with abnormal Electrocardiogram (ECG) |  | Baseline up to 14 days after last dose (Day 70) | 
| Number of participants with treatment emergent treatment-related adverse events |  | Baseline up to 35 days after last dose (Day 91) | 
| Number of participants with laboratory abnormalities |  | Baseline up to 14 days after last dose (Day 70) |