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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, End-Stage Kidney Disease

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Glipizide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin 25 mg<br> | Drug: Sitagliptin<br>* 25 mg (one 25-mg tablet) once daily<br>* Other names: MK-0431;|
| Active Comparator: Glipizide 2.5 mg - 20 mg<br> | Drug: Glipizide<br>* 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<br>* Other names: Glucotrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment | Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only. | Baseline / Week 54 | 
| Number of Participants With Clinical Adverse Events | Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy. | 54 Week Treatment Period + 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Symptomatic Hypoglycemic Adverse Events | A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level. | 54 Week Treatment Period + 28 days | 
| Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks. | Baseline / Week 54 | 
| Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment | Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. | Baseline / Week 54 |