Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

• Status: Completed
• Trial end date: 2011-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Glipizide; Sitagliptin Phosphate

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.