A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Condition: Chronic Renal Insufficiency; Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Intervention: Omarigliptin
Intervention description: Single oral dose of 3 mg (3 x 1-mg capsules)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a 2-part study in participants with renal impairment and matched healthy participants
      to investigate the effect of impaired renal function on the plasma and urine levels of
      omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
    

Eligibility criteria:

        Inclusion Criteria:

        Impaired Renal Function Subjects:

          -  Females of reproductive potential must have a negative pregnancy test and agree to use
             2 methods of birth control

          -  Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR)
             calculated using the Modification of Diet in Renal Disease (MDRD) equation

        Healthy Subjects:

          -  Females of reproductive potential must have a negative pregnancy test and agree to use
             2 methods of birth control;

          -  In general good health

        Exclusion Criteria:

        Impaired Renal Function Subjects:

          -  Is mentally or legally incapacitated

          -  Has rapidly fluctuating renal function or has demonstrated or suspected renal artery
             stenosis

          -  History of significant endocrine (other than Type 2 diabetes), gastrointestinal,
             cardiovascular, hematological, immunological, respiratory, or genitourinary diseases

          -  History of stroke, chronic seizures or major neurological disease

          -  Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis

          -  History of cancer (Some exceptions apply)

          -  Regular user of barbiturates or sleep aides

          -  Consumes excessive amounts of alcohol (more than 2 drinks/day)

          -  Consumes excessive amounts of caffeinated beverages (more than 6/day)

          -  Has had major surgery or has lost or donated 1 unit of blood within 4 weeks

          -  Has a history of significant multiple and/or severe allergies

          -  Current or history of illicit drug abuse

          -  Nursing mothers

        Healthy Subjects:

          -  Is mentally or legally incapacitated;

          -  Has a history of stroke, chronic seizures, or major neurological disorder

          -  Renal impairment

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, immunological, respiratory, or genitourinary diseases

          -  Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis

          -  History of cancer (Some exceptions apply)

          -  Regular user of barbiturates or sleep aides

          -  Consumes excessive amounts of alcohol (more than 2 drinks/day)

          -  Consumes excessive amounts of caffeinated beverages (more than 6/day)

          -  Has had major surgery or has lost or donated 1 unit of blood within 4 weeks

          -  Has a history of significant multiple and/or severe allergies

          -  Current or history of illicit drug abuse

          -  Nursing mothers