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Clinical Trials List

Protocol NumberC3421005
NCT Number(ClinicalTrials.gov Identfier)NCT03985293
Completed

2019-10-15 - 2021-06-01

Phase II

Recruiting4

Terminated1

ICD-10E11.9

Type 2 diabetes mellitus without complications

ICD-10E13.9

Other specified diabetes mellitus without complications

ICD-9250.00

Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled

A 16-Week, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily PF-06882961 Administration in Adults with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin or Diet and Exercise.

  • Sponsor

    Pfizer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator I-TE LEE Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊純宜 Division of Endocrinology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Cheng Kung University Hospital Dou-Liou Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Diabetes Mellitus, Type 2

Objectives

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Test Drug

PF-06882961

Active Ingredient

PF-06882961

Dosage Form

Tablet

Dosage

2.5 mg, 10 mg, 40 mg, 100 mg

Endpoints

Primary Outcome Measures:
1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16.


Secondary Outcome Measures:
1. Percentage of Participants Achieving Less Than (<) 7% Glycosylated Hemoglobin (HbA1c) Levels.
2. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 2.
3. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 4.
4. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 6.
5. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 8.
6. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12.
7. Change from baseline in fasting plasma glucose at week 2.
8. Change from baseline in fasting plasma glucose at week 4.
9. Change from baseline in fasting plasma glucose at week 6.
10. Change from baseline in fasting plasma glucose at week 8.
11. Change from baseline in fasting plasma glucose at week 12.
12. Change from baseline in fasting plasma glucose at week 16.
13. Change from baseline in body weight at week 2.
14. Change from baseline in body weight at week 4.
15. Change from baseline in body weight at week 6.
16. Change from baseline in body weight at week 8.
17. Change from baseline in body weight at week 12.
18. Change from baseline in body weight at week 16.
19. Incidence of treatment emergent adverse events (AEs and SAEs).
20. Incidence of treatment emergent clinical laboratory abnormalities.
21. Incidence of treatment emergent vital signs abnormalities.
22. Incidence of treatment emergent ECG abnormalities.

Inclution Criteria

1.Patients with T2DM who are treated with metformin and/or diet and exercise.
2.HbA1c greater than or equal to 7% and less than or equal to 10.5%.
3.Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2.

Exclusion Criteria

1. Any condition possibly affecting drug absorption.
2. Diagnosis of Type 1 diabetes.
3. History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening.
4. Any malignancy not considered cured.
5. Personal or family history of MTC or MEN2, or participants with suspected MTC.
6. Acute pancreatitis or history of chronic pancreatitis.
7. Symptomatic gallbladder disease.
8. Known medical history of active proliferative retinopathy and/or macular edema.
9. Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis.
10. Known history of HIV.
11. Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic).
12. Clinically relevant ECG abnormalities.
13. Positive urine drug test.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    400 participants

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