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Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

Primary Purpose

Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin
Glipizide
Placebo for Sitagliptin
Placebo for Glipizide
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

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Has moderate or severe renal insufficiency

Exclusion Criteria:

  • Has type 1 diabetes mellitus or a history of ketoacidosis
  • Is on a new weight loss program
  • Has active liver disease
  • Is on dialysis or is likely to need dialysis during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sitagliptin

    Glipizide

    Arm Description

    Sitagliptin + Placebo for Glipizide

    Glipizide + Placebo for Sitagliptin

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
    A1C represents percentage of glycosylated hemoglobin.
    Percentage of Participants With Hypoglycemic Events
    Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.

    Secondary Outcome Measures

    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
    Change From Baseline in Body Weight at Week 54

    Full Information

    First Posted
    July 27, 2007
    Last Updated
    April 7, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00509262
    Brief Title
    Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
    Official Title
    A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 9, 2007 (Actual)
    Primary Completion Date
    March 16, 2011 (Actual)
    Study Completion Date
    March 16, 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin
    Arm Type
    Experimental
    Arm Description
    Sitagliptin + Placebo for Glipizide
    Arm Title
    Glipizide
    Arm Type
    Active Comparator
    Arm Description
    Glipizide + Placebo for Sitagliptin
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    MK-0431, Januvia
    Intervention Description
    Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
    Intervention Type
    Drug
    Intervention Name(s)
    Glipizide
    Other Intervention Name(s)
    Glucotrol
    Intervention Description
    Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Sitagliptin
    Intervention Description
    Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Glipizide
    Intervention Description
    Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
    Description
    A1C represents percentage of glycosylated hemoglobin.
    Time Frame
    Baseline to Week 54
    Title
    Percentage of Participants With Hypoglycemic Events
    Description
    Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.
    Time Frame
    Baseline up to 28 days following the last dose of study therapy
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
    Time Frame
    Baseline to Week 54
    Title
    Change From Baseline in Body Weight at Week 54
    Time Frame
    Baseline to Week 54

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has type 2 diabetes mellitus Has moderate or severe renal insufficiency Exclusion Criteria: Has type 1 diabetes mellitus or a history of ketoacidosis Is on a new weight loss program Has active liver disease Is on dialysis or is likely to need dialysis during the study

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23248197
    Citation
    Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.
    Results Reference
    result

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    Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

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