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

NCT02554877 | Completed Phase 2 Results

• 1 other identifier: B4801010
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 38

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo

  HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.

  Baseline, Week 12

Secondary Outcomes (13)

• Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8

  Baseline, Weeks 2, 4, 8

• Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12

  Baseline, Weeks 2,4,8 and 12

• Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.

  Week 12

• Number of Participants With Laboratory Test Abnormalities

  Baseline up to 98 days

• Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria

  Baseline up to Day 98

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PF-06291874, 30 mg

EXPERIMENTAL

Drug: PF-06291874

PF-06291874, 60 mg

EXPERIMENTAL

Drug: PF-06291874

PF-06291874, 100 mg

EXPERIMENTAL

Drug: PF-06291874

Interventions

PF-06291874 DRUG

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

PF-06291874, 100 mg; PF-06291874, 30 mg; PF-06291874, 60 mg

Placebo DRUG

oral tablet

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
• 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
• 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;
• Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
• 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
• Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
• 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
• 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
• Subjects with an arm circumference \>52 cm measured at the midpoint of the length of the upper arm;
• 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);
• Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
• Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Sierra Clinical Research

Roseville, California, 95661, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

Diablo Clinical Research, Inc

Walnut Creek, California, 94598, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Suncoast Research Group, Llc

Miami, Florida, 33135, United States

Location

QPS-MRA, LLC (Miami Research Associates)

South Miami, Florida, 33143, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, 70006, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63141, United States

Location

ALAS Science Clinical Research

Las Vegas, Nevada, 89120, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Clinilabs Inc.

Eatontown, New Jersey, 07724, United States

Location

Pharmaceutical Research Associates, Inc.

Marlton, New Jersey, 08053, United States

Location

TLB Research

Trenton, New Jersey, 08611, United States

Location

Randolph Medical Associates

Asheboro, North Carolina, 27203, United States

Location

High Point Clinical Trials Center, LLC

High Point, North Carolina, 27265, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58103, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Juno Research, LLC

Houston, Texas, 77074, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Juno Research, LLC

Katy, Texas, 77450, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Northeast Clinical Research of San Antonio, LLC

Schertz, Texas, 78154, United States

Location

National Clinical Research - Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

LMC Clinical Research Inc. (Thornhill)

Thornhill, Ontario, L4J 8L7, Canada

Location

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Manna Research Inc.

Lévis, Quebec, G6W 0M6, Canada

Location

Omnispec Clinical Research, Inc.

Mirabel, Quebec, J7J 2K8, Canada

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: September 17, 2015
• First Posted: September 18, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-07

Locations

CA (6); US (32)