search
Back to results

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo to Ertugliflozin
Ertugliflozin 1 mg
Ertugliflozin 5 mg
Ertugliflozin 25 mg
Sitagliptin 100 mg
Placebo to Sitagliptin
Metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Phase 2, safety and efficacy study with ertugliflozin (PF-04971729, MK-8835), Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2

Exclusion Criteria:

  • Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Placebo

    Ertugliflozin 1 mg

    Ertugliflozin 5 mg

    Ertugliflozin 10 mg

    Ertugliflozin 25 mg

    Sitagliptin 100 mg

    Arm Description

    Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days

    Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days

    Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days

    Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

    Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days

    Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days

    Outcomes

    Primary Outcome Measures

    Baseline Hemoglobin A1c (HbA1c)
    HbA1c is measured as percent.
    Change From Baseline in HbA1c at Week 12
    HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).

    Secondary Outcome Measures

    Change From Baseline in HbA1C at Week 2
    HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Change From Baseline in HbA1c at Week 4
    HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Change From Baseline in HbA1c at Week 8
    HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Baseline Body Weight
    Percent Change From Baseline in Body Weight at Week 12
    The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Percent Change From Baseline in Body Weight at Week 2
    The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Percent Change From Baseline in Body Weight at Week 4
    The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Percent Change From Baseline in Body Weight at Week 8
    The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Baseline Systolic Blood Pressure
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
    Change From Baseline in Systolic Blood Pressure at Week 12
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Change From Baseline in Systolic Blood Pressure at Week 2
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Change From Baseline in Systolic Blood Pressure at Week 4
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Change From Baseline in Systolic Blood Pressure at Week 8
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Baseline Diastolic Blood Pressure
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
    Change From Baseline in Diastolic Blood Pressure at Week 12
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Change From Baseline in Diastolic Blood Pressure at Week 2
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Change From Baseline in Diastolic Blood Pressure at Week 4
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Change From Baseline in Diastolic Blood Pressure at Week 8
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Baseline Fasting Plasma Glucose
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Change From Baseline in Fasting Plasma Glucose at Week 12
    The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Change From Baseline in Fasting Plasma Glucose at Week 2
    The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Change From Baseline in Fasting Plasma Glucose at Week 4
    The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Change From Baseline in Fasting Plasma Glucose at Week 8
    The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Percentage of Participants Achieving HbA1c <7% at Week 12
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Percentage of Participants Achieving HbA1C <6.5% at Week 12
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Number of Participants Who Experienced an Advere Event (AE)
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.
    Number of Participants Who Discontinued Study Medication Due to an AE
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.

    Full Information

    First Posted
    January 29, 2010
    Last Updated
    August 15, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01059825
    Brief Title
    Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
    Official Title
    A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 24, 2010 (Actual)
    Primary Completion Date
    January 20, 2011 (Actual)
    Study Completion Date
    January 20, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Pfizer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Phase 2, safety and efficacy study with ertugliflozin (PF-04971729, MK-8835), Type 2 diabetes mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    375 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
    Arm Title
    Ertugliflozin 1 mg
    Arm Type
    Experimental
    Arm Description
    Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
    Arm Title
    Ertugliflozin 5 mg
    Arm Type
    Experimental
    Arm Description
    Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
    Arm Title
    Ertugliflozin 10 mg
    Arm Type
    Experimental
    Arm Description
    Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
    Arm Title
    Ertugliflozin 25 mg
    Arm Type
    Experimental
    Arm Description
    Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
    Arm Title
    Sitagliptin 100 mg
    Arm Type
    Active Comparator
    Arm Description
    Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Ertugliflozin
    Intervention Description
    Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ertugliflozin 1 mg
    Intervention Description
    Tablet, 1 mg, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ertugliflozin 5 mg
    Intervention Description
    Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ertugliflozin 25 mg
    Intervention Description
    Tablet, 25 mg, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin 100 mg
    Other Intervention Name(s)
    Januvia®, Tesavel®, Xelevia®, Ristaben®
    Intervention Description
    Tablet, 100 mg, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Sitagliptin
    Intervention Description
    Tablet, matching placebo to 100 mg, once daily for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Intervention Description
    Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
    Primary Outcome Measure Information:
    Title
    Baseline Hemoglobin A1c (HbA1c)
    Description
    HbA1c is measured as percent.
    Time Frame
    Baseline
    Title
    Change From Baseline in HbA1c at Week 12
    Description
    HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).
    Time Frame
    Baseline and Week 12
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in HbA1C at Week 2
    Description
    HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in HbA1c at Week 4
    Description
    HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in HbA1c at Week 8
    Description
    HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
    Time Frame
    Baseline and Week 8
    Title
    Baseline Body Weight
    Time Frame
    Baseline
    Title
    Percent Change From Baseline in Body Weight at Week 12
    Description
    The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Time Frame
    Baseline and Week 12
    Title
    Percent Change From Baseline in Body Weight at Week 2
    Description
    The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Time Frame
    Baseline and Week 2
    Title
    Percent Change From Baseline in Body Weight at Week 4
    Description
    The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Time Frame
    Baseline and Week 4
    Title
    Percent Change From Baseline in Body Weight at Week 8
    Description
    The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
    Time Frame
    Baseline and Week 8
    Title
    Baseline Systolic Blood Pressure
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
    Time Frame
    Baseline
    Title
    Change From Baseline in Systolic Blood Pressure at Week 12
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Systolic Blood Pressure at Week 2
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in Systolic Blood Pressure at Week 4
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in Systolic Blood Pressure at Week 8
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 8
    Title
    Baseline Diastolic Blood Pressure
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
    Time Frame
    Baseline
    Title
    Change From Baseline in Diastolic Blood Pressure at Week 12
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Diastolic Blood Pressure at Week 2
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in Diastolic Blood Pressure at Week 4
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in Diastolic Blood Pressure at Week 8
    Description
    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
    Time Frame
    Baseline and Week 8
    Title
    Baseline Fasting Plasma Glucose
    Description
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Baseline
    Title
    Change From Baseline in Fasting Plasma Glucose at Week 12
    Description
    The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Fasting Plasma Glucose at Week 2
    Description
    The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in Fasting Plasma Glucose at Week 4
    Description
    The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in Fasting Plasma Glucose at Week 8
    Description
    The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Baseline and Week 8
    Title
    Percentage of Participants Achieving HbA1c <7% at Week 12
    Description
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Week 12
    Title
    Percentage of Participants Achieving HbA1C <6.5% at Week 12
    Description
    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
    Time Frame
    Week 12
    Title
    Number of Participants Who Experienced an Advere Event (AE)
    Description
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.
    Time Frame
    Up to 98 days
    Title
    Number of Participants Who Discontinued Study Medication Due to an AE
    Description
    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.
    Time Frame
    Up to 84 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2 Exclusion Criteria: Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25754396
    Citation
    Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
    Results Reference
    result
    PubMed Identifier
    34213819
    Citation
    Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
    Results Reference
    derived

    Learn more about this trial

    Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

    We'll reach out to this number within 24 hrs