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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2; End-Stage Kidney Disease

Intervention: Sitagliptin (Drug); Glipizide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment

Number of Participants With Clinical Adverse Events

Secondary outcome:

Number of Participants With Symptomatic Hypoglycemic Adverse Events

Change From Baseline in Fasting Plasma Glucose (FPG)

Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment


Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: October 2007
Last updated: March 23, 2015

Page last updated: August 23, 2015

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