A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)

Last updated: October 22, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Nephropathy

Treatment

N/A

Clinical Study ID

NCT02532855
0431-838
MK-0431-838
2014-005525-13
  • Ages > 25
  • All Genders

Study Summary

The purpose of the study is to assess the effect of the addition of sitagliptin to metformin with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after 24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in participants treated with the addition of sitagliptin is non-inferior compared to that in participants treated with the addition of dapagliflozin after 24 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Have T2DM at Screening visit

  • Be on metformin monotherapy ≥1500 mg/day alone or in combination with an sulfonylureaagent (at a dose of ≥ 50% maximum labeled dose in the country of the investigationalsite) for ≥8 weeks

  • Is a male or a female not of reproductive potential (defined as one who ispostmenopausal or has had a hysterectomy and/or bilateral oophorectomy, or hadbilateral tubal ligation or occlusion at least 6 weeks prior to Screening visit). Ifparticipant is a female of reproductive potential, must agree to remain abstinent fromheterosexual activity or agrees to use (or have her partner use) acceptablecontraception to prevent pregnancy while receiving blinded study drug and for 14 daysafter the last dose of blinded study drug

Exclusion

Exclusion Criteria:

  • Has a history of type 1 diabetes mellitus or a history of ketoacidosis

  • Has a history of secondary causes of diabetes

  • Has a known hypersensitivity or intolerance to any dipeptidyl peptidase IV (DPP-4)inhibitor or sodium-glucose cotransporter 2 (SGLT2) inhibitor

  • Has been treated with any anti-hyperglycemic agents (AHA) other than metformin and forparticipants on dual combination therapy, a sulfonylurea within 12 weeks of screening

  • Intends to initiate weight loss medication during the study period

  • Has undergone bariatric surgery within 12 months of Screening visit

  • Has started a weight loss medication or a medication associated with weight changeswithin the prior 12 weeks.

  • Has a history of myocardial infarction, unstable angina, arterial revascularization,stroke, transient ischemic attack, heart failure within 3 months of Screening visit

  • Has a history of malignancy ≤5 years prior to study, except for adequately treatedbasal cell or squamous cell skin cancer or in situ cervical cancer

  • Has human immunodeficiency virus (HIV)

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

  • Has a medical history of active liver disease (other than non-alcoholic hepaticsteatosis), including chronic hepatitis B or C, primary biliary cirrhosis, orsymptomatic gallbladder disease

  • Is currently being treated for hyperthyroidism or is on thyroid replacement therapyand has not been on a stable dose for at least 6 weeks prior to Screening visit

  • Is on or likely to require treatment for ≥14 consecutive days or repeated courses ofcorticosteroids

  • Is on or likely to require treatment for ≥7 consecutive days with non-steroidalanti-inflammatory drugs

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

  • Is planning to undergo hormonal therapy in preparation to donate eggs during thestudy, including 14 days following the last dose of blinded study drug

  • Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week orengages in binge drinking

  • Has donated blood or blood products within 6 weeks of Screening visit or who plans todonate blood or blood products at any time during the study

Study Design

Total Participants: 614
Study Start date:
October 20, 2015
Estimated Completion Date:
October 10, 2017

Connect with a study center

  • Merck Sharp & Dohme (Argentina) Inc.

    Buenos Aires,
    Argentina

    Site Not Available

  • Merck Sharp & Dohme

    North Ryde,
    Australia

    Site Not Available

  • MSD Brasil

    Sao Paulo,
    Brazil

    Site Not Available

  • Merck Canada

    Kirkland, Quebec H9H 3L1
    Canada

    Site Not Available

  • MDS Colombia SAS

    Bogota,
    Colombia

    Site Not Available

  • Merck Sharp & Dohme OU

    Tallinn,
    Estonia

    Site Not Available

  • MSD Finland Oy

    Espoo,
    Finland

    Site Not Available

  • MSD Sharp & Dohme GmbH

    Haar,
    Germany

    Site Not Available

  • MSD Pharma Hungary Kft.

    Budapest,
    Hungary

    Site Not Available

  • MSD Ireland (Human Health) Ltd.

    Dublin,
    Ireland

    Site Not Available

  • MSD Korea LTD

    Seoul,
    Korea, Republic of

    Site Not Available

  • Merck Sharp & Dohme Latvija SIA

    Riga,
    Latvia

    Site Not Available

  • UAB "Merck Sharp & Dohme"

    Vilnius,
    Lithuania

    Site Not Available

  • MSD

    Mexico City,
    Mexico

    Site Not Available

  • Merck Sharp & Dohme (New Zealand) Ltd.

    Wellington,
    New Zealand

    Site Not Available

  • MSD Norge A/S

    Drammen,
    Norway

    Site Not Available

  • Merck Sharp & Dohme, Peru S.R.L.

    Lima,
    Peru

    Site Not Available

  • Call for Information (Investigational Site 0203)

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Call for Information (Investigational Site 0207)

    Cidra, 00739
    Puerto Rico

    Site Not Available

  • Call for Information (Investigational Site 0202)

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Call for Information (Investigational Site 0204)

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Merck Sharp & Dohme Romania SRL

    Bucharest,
    Romania

    Site Not Available

  • Merck Sharp & Dohme IDEA, Inc.

    Moscow,
    Russian Federation

    Site Not Available

  • MSD (Pty) LTD South Africa

    Midrand,
    South Africa

    Site Not Available

  • Merck Sharp and Dohme de Espana S.A.

    Madrid,
    Spain

    Site Not Available

  • Merck Sharp & Dohme Ltd.

    Hoddesdon,
    United Kingdom

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    Huntington Park, California 90255
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    Los Angeles, California 90036
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    San Marino, California 91108
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    Simi Valley, California 93065
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    Colorado Springs, Colorado 80909
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    Denver, Colorado 80246
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    Cooper City, Florida 33024
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    Debary, Florida 32713
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    Hialeah, Florida 33012
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    Jacksonville, Florida 32256
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    Sunset, Louisiana 70584
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  • Call for Information (Investigational Site 0066)

    Portland, Maine 04101
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  • Call for Information (Investigational Site 0016)

    Elkridge, Maryland 21075
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  • Call for Information (Investigational Site 0067)

    St. Louis, Missouri 63122
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  • Call for Information (Investigational Site 0020)

    Canal Fulton, Ohio 44614
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    Centerville, Ohio 45459
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  • Call for Information (Investigational Site 0002)

    Columbus, Ohio 43215
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  • Call for Information (Investigational Site 0019)

    Lyndhurst, Ohio 44124
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  • Call for Information (Investigational Site 0023)

    Oklahoma City, Oklahoma 73112
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  • Call for Information (Investigational Site 0075)

    Lansdale, Pennsylvania 19446
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    Pittsburgh, Pennsylvania 15236
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  • Call for Information (Investigational Site 0054)

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  • Call for Information (Investigational Site 0106)

    Franklin, Tennessee 37067
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  • Call for Information (Investigational Site 0040)

    Kingsport, Tennessee 37660
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  • Call for Information (Investigational Site 2510)

    Nashville, Tennessee 37211
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  • Call for Information (Investigational Site 0087)

    Smyrna, Tennessee 37167
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  • Call for Information (Investigational Site 0034)

    Dallas, Texas 75254
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  • Call for Information (Investigational Site 0050)

    Fort Worth, Texas 76104
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  • Call for Information (Investigational Site 0092)

    Houston, Texas 77008
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  • Call for Information (Investigational Site 0097)

    San Antonio, Texas 78258
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  • Call for Information (Investigational Site 0031)

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Call for Information (Investigational Site 0018)

    Richmond, Virginia 23114
    United States

    Site Not Available

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