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

NCT02175121 | Completed Phase 2 Results

• 1 other identifier: B4801011
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)

  An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.

  Baseline up to 10-14 days after last dose of study drug, up to 42 days

• Number of Participants With Laboratory Test Abnormalities

  The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.

  Baseline up to 10-14 days after last dose of study drug, up to 42 days

• Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern

  Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm).

  Baseline up to 10-14 days after last dose of study drug, up to 42 days

• Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern

  ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 msec; \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 milliseconds (msec); \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec.

  Baseline up to 10-14 days after last dose of study drug, up to 42 days

Secondary Outcomes (21)

• Change From Baseline in Mean Daily Glucose

  Baseline and Day 28

• Change From Baseline in Fasting Plasma Glucose

  Baseline, Day 14 and the mean of Days 28 and 29

• Percent Change From Baseline in Triglycerides

  Baseline, Day 14 and the mean of Days 28 and 29

• Percent Change From Baseline in Total Cholesterol

  Baseline, Day 14 and the mean of Days 28 and 29

• Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)

  Baseline, Day 14 and the mean of Days 28 and 29

Study Arms (5)

Treatment A- Placebo

PLACEBO COMPARATOR

Drug: Placebo

Treatment B- PF-06291874

EXPERIMENTAL

Drug: PF-06291874

Treatment C- PF-06291874

EXPERIMENTAL

Drug: PF-06291874

Treatment D- PF-06291874

EXPERIMENTAL

Drug: PF-06291874

Treatment E- PF-06291874

EXPERIMENTAL

Drug: PF-06291874

Interventions

Placebo DRUG

Tablet, once daily for 28 days

Treatment A- Placebo

PF-06291874 DRUG

Tablet, 15 mg, once daily for 28 days

Treatment B- PF-06291874

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

SeaView Research, Inc.

Miami, Florida, 33125, United States

Location

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Miami Research Associates, Inc.

South Miami, Florida, 33143, United States

Location

MRA Clinical Research, LLC

South Miami, Florida, 33143, United States

Location

MRA Clinical Research

South Miami, Florida, 33143, United States

Location

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Clinilabs, Inc.

Eatontown, New Jersey, 07724, United States

Location

PRA International

Marlton, New Jersey, 08053, United States

Location

Buffalo Clinical Research Center, LLC

Buffalo, New York, 14202, United States

Location

High Point Clinical Trials Center, LLC

High Point, North Carolina, 27265, United States

Location

Community Research

Cincinnati, Ohio, 45255, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PF-06291874

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 15, 2016
• Results First Posted: June 15, 2016

Record last verified: 2016-05

Locations

US (19)