Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)

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NCT02226003

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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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type 2 diabetes mellitus as per American Diabetes Association guidelines

- Not on antihyperglycemic agent (AHA) >=8 weeks with a Visit 1/Screening HbA1C >=8.0% and <=10.5% (>=64 mmol/mol and <=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol)

- Body mass index (BMI) >=18.0 kg/m^2

- Male or female not of reproductive potential

- Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.

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


- History of type 1 diabetes mellitus or diabetic ketoacidosis


- History of other specific types of diabetes (e.g., genetic syndromes, secondary
pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and
post-organ transplant


- A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2)
inhibitor or sitagliptin


- Has been treated with any of the following agents within 12 weeks of study start or
during the pre-randomization period: insulin of any type (except for short-term use
[i.e., <=7 days] during concomitant illness or other stress), other injectable
anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or
rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors,
dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™),
colesevelam (Welchol™), any other AHA with the exception of the protocol-approved
agents


- Is on a weight-loss program or weight-loss medication or other medication associated
with weight changes and is not weight stable prior to study start


- Has undergone bariatric surgery within the past 12 months or >12 months and is not
weight stable prior to study start


- A history of myocardial infarction, unstable angina, arterial revascularization,
stroke, transient ischemic attack, or New York Heart Association (NYHA) functional
Class III-IV heart failure within 3 months of study start


- Active, obstructive uropathy or indwelling urinary catheter


- History of malignancy <=5 years prior to study start, except for adequately treated
basal cell or squamous cell skin cancer or in situ cervical cancer


- A known history of human immunodeficiency virus (HIV)


- A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a
clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative
or myelodysplastic syndromes, thrombocytopenia)


- A medical history of active liver disease (other than non-alcoholic hepatic
steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or
symptomatic gallbladder disease


- Any clinically significant malabsorption condition


- Current treatment for hyperthyroidism


- On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior
study start


- On a previous clinical study with ertugliflozin


- Participated in other studies involving investigational drug(s) 30 days prior to study
start


- Surgical procedure within 6 weeks prior to study start or major surgery planned during
the trial


- Positive urine pregnancy test


- Pregnant or breast-feeding, or planning to conceive during the trial, including 14
days following the last dose of study medication


- Planning to undergo hormonal therapy in preparation for egg donation during the trial,
including 14 days following the last dose of study medication


- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or
engages in binge drinking


- Donated blood or blood products within 6 weeks of study start.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise
Brief Summary This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.
Detailed Description Each participant will be in the study for approximately 39 weeks including: a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a 2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Ertugliflozin
    Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.
  • Drug: Sitagliptin
    Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
  • Drug: Placebo to Ertugliflozin
    Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.
  • Drug: Placebo to Sitagliptin
    Matching placebo to sitagliptin administered orally, once daily for 26 weeks.
  • Drug: Glimepiride
    Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.
Study Arms  ICMJE
  • Experimental: Ertugliflozin 5 mg and Sitagliptin 100 mg
    Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Sitagliptin
    • Drug: Placebo to Ertugliflozin
    • Drug: Glimepiride
  • Experimental: Ertugliflozin 15 mg and Sitagliptin 100 mg
    Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Sitagliptin
    • Drug: Glimepiride
  • Placebo Comparator: Placebo to Ertugliflozin and Placebo to Sitagliptin
    Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
    Interventions:
    • Drug: Placebo to Ertugliflozin
    • Drug: Placebo to Sitagliptin
    • Drug: Glimepiride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)		291
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2014)		300
Actual Study Completion Date  ICMJE February 23, 2016
Actual Primary Completion Date February 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes mellitus as per American Diabetes Association guidelines
  • Not on antihyperglycemic agent (AHA) >=8 weeks with a Visit 1/Screening HbA1C >=8.0% and <=10.5% (>=64 mmol/mol and <=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, ?-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol) OR on low-dose dual combination therapy (?50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol)
  • Body mass index (BMI) >=18.0 kg/m^2
  • Male or female not of reproductive potential
  • Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.

Exclusion Criteria:

  • History of type 1 diabetes mellitus or diabetic ketoacidosis
  • History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant
  • A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2) inhibitor or sitagliptin
  • Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: insulin of any type (except for short-term use [i.e., <=7 days] during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset?), colesevelam (Welchol?), any other AHA with the exception of the protocol-approved agents
  • Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start
  • Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable prior to study start
  • A history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional Class III-IV heart failure within 3 months of study start
  • Active, obstructive uropathy or indwelling urinary catheter
  • History of malignancy <=5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • A known history of human immunodeficiency virus (HIV)
  • A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Any clinically significant malabsorption condition
  • Current treatment for hyperthyroidism
  • On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior study start
  • On a previous clinical study with ertugliflozin
  • Participated in other studies involving investigational drug(s) 30 days prior to study start
  • Surgical procedure within 6 weeks prior to study start or major surgery planned during the trial
  • Positive urine pregnancy test
  • Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication
  • Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication
  • Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking
  • Donated blood or blood products within 6 weeks of study start.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Bulgaria,   Czech Republic,   Estonia,   Hungary,   Israel,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT02226003
Other Study ID Numbers  ICMJE 8835-017
2014-001049-25 ( EudraCT Number )
B1521047 ( Other Identifier: Pfizer Protocol Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialD…
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP