Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

NCT02036515

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- Diagnosis of type 2 diabetes mellitus (T2DM)

- On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin

- Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2

- Male, postmenopausal female or surgically sterile female

- If a female of reproductive potential, agrees to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug

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 a history of ketoacidosis


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


- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2)
or DPP-4 inhibitor


- On a weight-loss program or weight-loss medication or other medication associated with
weight changes and is not weight stable


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


- Has been treated with insulin (except for short-term use [<= 7 days]), injectable
antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide),
pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2)
inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™),
colesevelam (Welchol™), or any other non-protocol approved AHAs within 12 weeks of
study participation


- Has active, obstructive uropathy or indwelling urinary catheter


- 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 participation


- A history of malignancy ≤5 years prior to study participation, except for adequately
treated basal or squamous cell skin cancer or in situ cervical cancer


- Known history of Human Immunodeficiency Virus (HIV)


- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or
any other clinically significant hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)


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


- Has any clinically significant malabsorption condition


- If taking thyroid replacement therapy, has not been on a stable dose for at least 6
weeks prior to study participation


- Has been previously randomized in a study with ertugliflozin


- Has participated in other studies involving an investigational drug within 30 days
prior or during study participation


- Has undergone a surgical procedure within 6 weeks prior to or planned major surgery
during study participation


- Has a positive urine pregnancy test


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


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


- Excessive consumption of alcoholic beverages or binge drinking


- Has donated blood or blood products within 6 weeks of study participation or plans to
donate blood or blood products at any time during the trial

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

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

Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin
Brief Summary This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
Detailed Description The duration of the trial will be approximately 69 weeks. This will include a 1-week Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone contact 14 days after the last dose of blinded investigational product.
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 5 mg
    Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
    Other Names:
    • MK-8835
    • PF-04971729
  • Drug: Ertugliflozin 15 mg
    Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks
    Other Names:
    • MK-8835
    • PF-04971729
  • Drug: Placebo for ertugliflozin 5 mg
    Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks
  • Drug: Metformin
    Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.
    Other Names:
    • Glucophage
    • Glucophage XR
  • Drug: Sitagliptin
    Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.
    Other Name: JANUVIA®
  • Drug: Glimepiride
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion
    Other Name: AMARYL
  • Biological: Insulin
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.
  • Drug: Placebo for ertugliflozin 10 mg
    Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks
Study Arms  ICMJE
  • Experimental: Ertugliflozin 5 mg
    Ertugliflozin, 5 mg, oral, once daily for 52 weeks
    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Metformin
    • Drug: Sitagliptin
    • Drug: Glimepiride
    • Biological: Insulin
    • Drug: Placebo for ertugliflozin 10 mg
  • Experimental: Ertugliflozin 15 mg
    Ertugliflozin, 15 mg, oral, once daily for 52 weeks
    Interventions:
    • Drug: Ertugliflozin 15 mg
    • Drug: Metformin
    • Drug: Sitagliptin
    • Drug: Glimepiride
    • Biological: Insulin
  • Placebo Comparator: Placebo
    Matching placebo to ertuglifozin, oral, once daily for 52 weeks
    Interventions:
    • Drug: Placebo for ertugliflozin 5 mg
    • Drug: Metformin
    • Drug: Sitagliptin
    • Drug: Glimepiride
    • Biological: Insulin
    • Drug: Placebo for ertugliflozin 10 mg
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: June 23, 2017)
464
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
405
Actual Study Completion Date  ICMJE June 6, 2016
Actual Primary Completion Date June 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus (T2DM)
  • On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin
  • Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2
  • Male, postmenopausal female or surgically sterile female
  • If a female of reproductive potential, agrees to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug- or chemical-induced, and post-organ transplant)
  • A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) or DPP-4 inhibitor
  • On a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable
  • Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable
  • Has been treated with insulin (except for short-term use [<= 7 days]), injectable antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2) inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset?), colesevelam (Welchol?), or any other non-protocol approved AHAs within 12 weeks of study participation
  • Has active, obstructive uropathy or indwelling urinary catheter
  • 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 participation
  • A history of malignancy ?5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
  • Known history of Human Immunodeficiency Virus (HIV)
  • Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • A medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease
  • Has any clinically significant malabsorption condition
  • If taking thyroid replacement therapy, has not been on a stable dose for at least 6 weeks prior to study participation
  • Has been previously randomized in a study with ertugliflozin
  • Has participated in other studies involving an investigational drug within 30 days prior or during study participation
  • Has undergone a surgical procedure within 6 weeks prior to or planned major surgery during study participation
  • Has a positive urine pregnancy test
  • Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of study medication
  • Planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of study medication
  • Excessive consumption of alcoholic beverages or binge drinking
  • Has donated blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
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,   Finland,   Hungary,   Israel,   Korea, Republic of,   Malaysia,   Romania,   Slovakia,   United States
 
Administrative Information
NCT Number  ICMJE NCT02036515
Other Study ID Numbers  ICMJE 8835-006
2013-003697-26 ( EudraCT Number )
B1521015 ( Other Identifier: Pfizer Study 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