Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

NCT01999218

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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

- Diagnosis of T2DM in accordance to American Diabetes Association guidelines

- On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.

- Body Mass Index (BMI) ≥18.0 kg/m^2

- Male or female not of reproductive potential

- If a female of reproductive potential, agree 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 or presence of type 1 diabetes mellitus or a history of ketoacidosis


- History of other specific types of diabetes (eg, 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 2 (SGLT2)
inhibitor


- Use of the following prohibited therapeutic agents within 12 weeks of study
participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or
rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam
(Welchol®), and any other non-approved anti-hyperglycemic therapy


- Known hypersensitivity or intolerance to metformin or glimepiride


- On a weight-loss program or medication or medication associated with weight changes
and is not weight-stable (>=5% change in body weight in the last 6 months)


- History of bariatric surgery less than 12 months prior to study participation


- 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


- Active, obstructive uropathy or an indwelling urinary catheter


- 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)


- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells


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


- Any clinically significant malabsorption condition


- Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been
at a stable dose for at least 6 weeks prior to study participation


- Previous randomization in a study with ertugliflozin


- Participation in other studies involving investigational drug(s) within 30 days of
study participation and/or during the pre-randomization period


- A surgical procedure within 6 weeks prior to study participation or planned major
surgery during the trial


- A positive urine pregnancy test


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


- Undergoing hormonal therapy in preparation to donate eggs during the period of the
trial, including 14 days following the last dose of study drug


- Consumption of more than 2 alcoholic drinks per day or engages in binge drinking


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

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Descriptive Information
Brief Title  ICMJE Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
Brief Summary This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.
Detailed Description The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled 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 5 mg
    Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104
    Other Name: MK-8835
  • Drug: Ertugliflozin 10 mg
    Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.
    Other Name: MK-8355
  • Drug: Glimerpiride
    Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose
  • Drug: Placebo to Ertugliflozin
    Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104
  • Drug: Placebo to Glimepiride
    Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.
  • 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. Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
  • Drug: Sitagliptin
    Open label, oral, once daily, rescue medication as required.
Study Arms  ICMJE
  • Experimental: Ertugliflozin 5 mg
    Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo to Ertugliflozin
    • Drug: Placebo to Glimepiride
    • Drug: Metformin
    • Drug: Sitagliptin
  • Experimental: Ertugliflozin 15 mg
    Ertugliflozin 15 mg QD from Day 1 to Week 104
    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Ertugliflozin 10 mg
    • Drug: Placebo to Glimepiride
    • Drug: Metformin
    • Drug: Sitagliptin
  • Active Comparator: Glimepiride up to 8 mg
    Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
    Interventions:
    • Drug: Glimerpiride
    • Drug: Placebo to Ertugliflozin
    • Drug: Metformin
    • Drug: Sitagliptin
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: April 26, 2017)
1326
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
1230
Actual Study Completion Date  ICMJE April 18, 2017
Actual Primary Completion Date April 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of T2DM in accordance to American Diabetes Association guidelines
  • On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
  • Body Mass Index (BMI) ?18.0 kg/m^2
  • Male or female not of reproductive potential
  • If a female of reproductive potential, agree 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 or presence of type 1 diabetes mellitus or a history of ketoacidosis
  • History of other specific types of diabetes (eg, 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 2 (SGLT2) inhibitor
  • Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
  • Known hypersensitivity or intolerance to metformin or glimepiride
  • On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)
  • History of bariatric surgery less than 12 months prior to study participation
  • 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
  • Active, obstructive uropathy or an indwelling urinary catheter
  • 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)
  • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
  • A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
  • Any clinically significant malabsorption condition
  • Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
  • Previous randomization in a study with ertugliflozin
  • Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
  • A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
  • A positive urine pregnancy test
  • Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
  • Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
  • Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
  • Donation of 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 Argentina,   Canada,   Czech Republic,   Hungary,   Korea, Republic of,   Lithuania,   Mexico,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT01999218
Other Study ID Numbers  ICMJE 8835-002
2013-003582-34 ( EudraCT Number )
B1521013 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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 March 2019

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