Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of Pf-06291874 Given As Monotherapy To Adults With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175121
• Other study ID #: B4801011
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2014
• Last updated: April 20, 2015
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.

• Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg

• HbA1c value at the screening visit meeting once of the following criteria:

• Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%

• Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%

• Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.

• Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Exclusion Criteria:

• History of Type 1 diabetes mellitus or secondary forms of diabetes

• One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.

• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.

• History or evidence of diabetic complications with significant end organ damage, such as

• Proliferative retinopathy and/or macular edema;

• Diabetic neuropathy complicated by neuropathic ulcers;

• Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;

• Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Placebo
Tablet, once daily for 28 days
• PF-06291874
Tablet, 15 mg, once daily for 28 days
• PF-06291874
Tablet, 35 mg, once daily for 28 days
• PF-06291874
Tablet, 75 mg, once daily for 28 days
• PF-06291874
Tablet, 150 mg, once daily for 28 days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Buffalo Clinical Research Center, LLC	Buffalo	New York
United States	Profil Institute for Clinical Research, Inc.	Chula Vista	California
United States	Community Research	Cincinnati	Ohio
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Clinilabs, Inc.	Eatontown	New Jersey
United States	High Point Clinical Trials Center, LLC	High Point	North Carolina
United States	Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky
United States	PRA International	Marlton	New Jersey
United States	SeaView Research, Inc.	Miami	Florida
United States	SeaView Research, Inc.	Miami	Florida
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Compass Research, LLC	Orlando	Florida
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Miami Research Associates, Inc.	South Miami	Florida
United States	MRA Clinical Research	South Miami	Florida
United States	MRA Clinical Research, LLC	South Miami	Florida
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG		Day 0 to Day 28	Yes
Secondary	mean daily glucose	plasma glucose level	Baseline and Day 28	No
Secondary	fasting plasma glucose	plasma glucose level in fasting state	Baseline, Day 14 and the mean of Day 28 and 29	No
Secondary	Change from Baseline in Lipid Parameters	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), non-HDL, oxidized LDL, LDL particle size and number, Lp-a, ApoB100 and Triglyceride blood concentrations.	Day 14 and mean of Day 28 and 29	No
Secondary	Area under the Concentration-Time Curve (AUC)	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption	Day 28	No
Secondary	Maximum Observed Plasma Concentration (Cmax)	peak or maximum observed concentration	Day 28	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)		Day 28	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Day 28	No
Secondary	Apparent Oral Clearance (CL/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	Day 28	No

External Links

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