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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 12-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-06291874 Administration In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554877
• Other study ID #: B4801010
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2015
• Last updated: September 15, 2016
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

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
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PF-06291874
study drug to be given as an oral tablet at 30, 60 or 100 mg
• Placebo
oral tablet

Locations

Country	Name	City	State
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Manna Research Inc.	Lévis	Quebec
Canada	Omnispec Clinical Research, Inc.	Mirabel	Quebec
Canada	LMC Clinical Research Inc. (Thornhill)	Thornhill	Ontario
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
Canada	Manna Research	Toronto	Ontario
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Randolph Medical Associates	Asheboro	North Carolina
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Aventiv Research	Columbus	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Clinilabs Inc.	Eatontown	New Jersey
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	High Point Clinical Trials Center, LLC	High Point	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Juno Research, LLC	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Juno Research, LLC	Katy	Texas
United States	ALAS Science Clinical Research	Las Vegas	Nevada
United States	National Research Institute	Los Angeles	California
United States	Pharmaceutical Research Associates, Inc.	Marlton	New Jersey
United States	Crescent City Clinical Research Center, LLC	Metairie	Louisiana
United States	Suncoast Research Group, Llc	Miami	Florida
United States	NRC Research Institute	Orange	California
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Sierra Clinical Research	Roseville	California
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Northeast Clinical Research of San Antonio, LLC	Schertz	Texas
United States	QPS-MRA, LLC (Miami Research Associates)	South Miami	Florida
United States	Encompass Clinical Research	Spring Valley	California
United States	St. Louis Clinical Trials, LC	St. Louis	Missouri
United States	TLB Research	Trenton	New Jersey
United States	Empire Clinical Research	Upland	California
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hemoglobin A1c (HbA1c)		Baseline, 12weeks	No
Secondary	Change from baseline in HbA1c (%)		at Baseline and Weeks 2, 4, & 8	No
Secondary	Change from baseline in fasting plasma glucose		at Baseline and weeks 2, 4, 8, and 12	No
Secondary	Proportion of subjects achieving HbA1C <7%		at Week 12	No
Secondary	Change from baseline in lipid parameters		at Baseline, Weeks 2, 4, 8, and 12	Yes
Secondary	Change from baseline in body weight		at Baseline, Weeks 2, 4, 8, and 12	No
Secondary	Proportion of subjects achieving HbA1C <6.5%		at Week 12	No

External Links

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