Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
Condition: Diabetes Mellitus, Type 2; End-Stage Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Glipizide
Intervention description: 25 mg (one 25-mg tablet) once daily; 2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg
Intervention MeSH terms: Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in
      participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who
      do not have adequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has T2DM.

          -  Participant is on dialysis on day of signing informed consent.

          -  Participant is unlikely to conceive or uses acceptable methods of birth control:
             hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide,
             contraceptive sponge, condom, or vasectomy.

          -  Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to
             Visit 4/Week -2.

          -  Participant is ≥85% compliant with study medication during the single-blind placebo
             run-in (as determined by tablet/capsule count) and compliant with diet, exercise and
             other run-in treatments during the run-in period.

        Exclusion Criteria:

          -  Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.

          -  Participant is losing weight in a weight loss program and is not in the maintenance
             phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight
             loss intervention outside that prescribed by the study.

          -  Participant has a clinically significant hematological disorder (e.g., aplastic
             anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).

          -  Participant has cirrhosis or active liver disease.

          -  Participant has been on dialysis for < 6 months.

          -  Participant has been diagnosed with a significant cardiovascular disorder and has new
             or worsening signs or symptoms of congestive heart failure within 3 months of signing
             informed consent.

          -  Participant has severe active peripheral vascular disease.

          -  Participant has a history of malignancy ≤ 5 years prior to signing informed consent,
             or > 5 years without documentation of remission/cure.

          -  Participant is under treatment for hyperthyroidism.

          -  Participant has a hypersensitivity or contraindication to glipizide.