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A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Gliclazide
Glimepiride
Metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • has T2DM
  • is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks
  • has a Visit 1/Screening HbA1C between 7.5% and 11.0%
  • is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication

Exclusion Criteria:

  • has a history of type 1 diabetes mellitus or a history of ketoacidosis
  • has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever

been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue

  • has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin
  • is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
  • has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
  • has a medical history of active liver disease
  • has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
  • has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
  • has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
  • has human immunodeficiency virus (HIV)
  • has severe peripheral vascular disease
  • is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
  • has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • has a clinically important hematological disorder (such as aplastic anemia,

myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

  • is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
  • is a user of recreational or illicit drugs or has had a recent history of drug abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sitagliptin

    Placebo

    Arm Description

    Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period.

    Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Number of Participants Who Experienced an Adverse Event
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
    Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

    Secondary Outcome Measures

    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

    Full Information

    First Posted
    May 1, 2012
    Last Updated
    July 20, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01590771
    Brief Title
    A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
    Official Title
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy, Alone or in Combination With Metformin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 9, 2012 (Actual)
    Primary Completion Date
    June 10, 2014 (Actual)
    Study Completion Date
    June 24, 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    498 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    Januvia®, MK-0431
    Intervention Description
    Sitagliptin 100 mg oral tablet once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo to sitagliptin oral tablet once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Gliclazide
    Intervention Description
    Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Glimepiride
    Intervention Description
    Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    Description
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Number of Participants Who Experienced an Adverse Event
    Description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
    Time Frame
    Up to 26 weeks
    Title
    Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    Description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
    Time Frame
    Up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    Description
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
    Description
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
    Description
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    Description
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin
    Description
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    Description
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
    Description
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
    Description
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
    Time Frame
    Baseline and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: has T2DM is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks has a Visit 1/Screening HbA1C between 7.5% and 11.0% is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication Exclusion Criteria: has a history of type 1 diabetes mellitus or a history of ketoacidosis has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months has undergone a surgical procedure within 4 weeks or has planned major surgery during the study has a medical history of active liver disease has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg has human immunodeficiency virus (HIV) has severe peripheral vascular disease is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication is a user of recreational or illicit drugs or has had a recent history of drug abuse

    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
    27502307
    Citation
    Ba J, Han P, Yuan G, Mo Z, Pan C, Wu F, Xu L, Hanson ME, Engel SS, Shankar RR. Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin. J Diabetes. 2017 Jul;9(7):667-676. doi: 10.1111/1753-0407.12456. Epub 2016 Sep 13.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0431-253&kw=0431-253&tab=access

    Learn more about this trial

    A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

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