A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)

NCT01986855

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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
25 + 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 in accordance with American Diabetes Association guidelines

- Have Stage 3 chronic kidney disease

- On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents [AHA] monotherapy or combination therapy) for at least 6 weeks prior to study participation OR on metformin (with or without diet/exercise therapy or other AHA therapy) and is willing to undergo a 10-week metformin wash-off period

- Have an estimated glomerular filtration rate (eGFR) of ≥30 to <60 mL/min/1.73m^2

- 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)


- History of nephrotic range proteinuria with hypoalbuminemia and edema


- History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic
vasculitis, renal artery stenosis with renovascular hypertension, or ischemic
nephropathy


- History of familial renal glucosuria


- History of renal dialysis or renal transplant or renal disease requiring treatment
with any immunosuppressive agent


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


- Has been treated with rosiglitazone or other SGLT2 inhibitors 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 non-alcoholic 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 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

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Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
Brief Summary This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this 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 to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
Detailed Description Participants who meet protocol-defined glycemic rescue criteria will be permitted to have an adjustment in the dose(s) of background antihyperglycemic agent (AHA) therapy or addition of new AHA therapy as directed by their investigator until the participant no longer meets the rescue criteria.
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: Placebo 5 mg
    Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks
  • Drug: Ertugliflozin 10 mg
    Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
    Other Names:
    • MK-8835
    • PF-04971729
  • Drug: Placebo 10 mg
    Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
Study Arms  ICMJE
  • Experimental: Ertugliflozin (5 mg)
    Ertugliflozin, 5 mg, oral, one 5 mg ertugliflozin tablet and one placebo tablet, once daily for 52 weeks
    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo 10 mg
  • Experimental: Ertugliflozin (15 mg)
    Ertugliflozin, 15 mg, oral, one 5 mg and one 10 mg tablet, once daily for 52 weeks
    Intervention: Drug: Ertugliflozin 10 mg
  • Placebo Comparator: Placebo
    Matching placebo
    Interventions:
    • Drug: Placebo 5 mg
    • Drug: Placebo 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: November 12, 2013)
468
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 28, 2016
Actual Primary Completion Date September 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Type 2 diabetes mellitus in accordance with American Diabetes Association guidelines
  • Have Stage 3 chronic kidney disease
  • On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents [AHA] monotherapy or combination therapy) for at least 6 weeks prior to study participation OR on metformin (with or without diet/exercise therapy or other AHA therapy) and is willing to undergo a 10-week metformin wash-off period
  • Have an estimated glomerular filtration rate (eGFR) of ?30 to <60 mL/min/1.73m^2
  • 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)
  • History of nephrotic range proteinuria with hypoalbuminemia and edema
  • History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic vasculitis, renal artery stenosis with renovascular hypertension, or ischemic nephropathy
  • History of familial renal glucosuria
  • History of renal dialysis or renal transplant or renal disease requiring treatment with any immunosuppressive agent
  • A known hypersensitivity or intolerance to any (sodium-glucose co-transporter 2) SGLT2 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
  • Has been treated with rosiglitazone or other SGLT2 inhibitors 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 non-alcoholic 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 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 25 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,   Bulgaria,   Colombia,   Hungary,   Israel,   Mexico,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01986855
Other Study ID Numbers  ICMJE 8835-001
2013-003587-31 ( EudraCT Number )
B1521016 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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