A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

NCT ID: NCT02554877

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Detailed Description

This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral tablet

PF-06291874, 30 mg

Group Type: EXPERIMENTAL

PF-06291874

Intervention Type: DRUG

study drug to be given as an oral tablet at 30, 60 or 100 mg

PF-06291874, 60 mg

Group Type: EXPERIMENTAL

PF-06291874

Intervention Type: DRUG

study drug to be given as an oral tablet at 30, 60 or 100 mg

PF-06291874, 100 mg

Group Type: EXPERIMENTAL

PF-06291874

Intervention Type: DRUG

study drug to be given as an oral tablet at 30, 60 or 100 mg

Interventions

PF-06291874

study drug to be given as an oral tablet at 30, 60 or 100 mg

Intervention Type: DRUG

Placebo

oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential

2. Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD

3. HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)

Exclusion Criteria

1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;

2. Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary

3. History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;

4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency

5. Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary

6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies

7. Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements

8. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility

9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;

10. History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);

11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;

12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Anaheim Clinical Trials, LLC

Anaheim, California, United States

National Research Institute

Los Angeles, California, United States

NRC Research Institute

Orange, California, United States

Sierra Clinical Research

Roseville, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Empire Clinical Research

Upland, California, United States

Diablo Clinical Research, Inc

Walnut Creek, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Suncoast Research Group, Llc

Miami, Florida, United States

QPS-MRA, LLC (Miami Research Associates)

South Miami, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, United States

St. Louis Clinical Trials, LC

St Louis, Missouri, United States

ALAS Science Clinical Research

Las Vegas, Nevada, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Clinilabs Inc.

Eatontown, New Jersey, United States

Pharmaceutical Research Associates, Inc.

Marlton, New Jersey, United States

TLB Research

Trenton, New Jersey, United States

Randolph Medical Associates

Asheboro, North Carolina, United States

High Point Clinical Trials Center, LLC

High Point, North Carolina, United States

Lillestol Research, LLC

Fargo, North Dakota, United States

Aventiv Research

Columbus, Ohio, United States

Juno Research, LLC

Houston, Texas, United States

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Juno Research, LLC

Katy, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Northeast Clinical Research of San Antonio, LLC

Schertz, Texas, United States

National Clinical Research - Richmond, Inc.

Richmond, Virginia, United States

Aggarwal and Associates Limited

Brampton, Ontario, Canada

LMC Clinical Research Inc. (Thornhill)

Thornhill, Ontario, Canada

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, Canada

Manna Research

Toronto, Ontario, Canada

Manna Research Inc.

Lévis, Quebec, Canada

Omnispec Clinical Research, Inc.

Mirabel, Quebec, Canada

Countries

United States; Canada

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4801010

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

Other Identifiers

B4801010

Identifier Type: -

Identifier Source: org_study_id