You are here

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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 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;

NCT02554877
Pfizer
Completed
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Her2(-) Breast Cancer ER/PR(+)
NCT02924584
All Genders
0+
Years
Tainan City,
Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
NCT02573259
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Ovarian Cancer HR+ HER2- Metastatic Breast Cancer
NCT03519178
All Genders
18+
Years
Multiple Sites
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
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
The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: PF-06291874
    study drug to be given as an oral tablet at 30, 60 or 100 mg
  • Drug: Placebo
    oral tablet
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06291874, 30 mg
    Intervention: Drug: PF-06291874
  • Experimental: PF-06291874, 60 mg
    Intervention: Drug: PF-06291874
  • Experimental: PF-06291874, 100 mg
    Intervention: Drug: PF-06291874
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
August 2016
August 2016   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02554877
B4801010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now