Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

Study Overview
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Brief Summary
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The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Official Title
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A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control

Conditions
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Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Glipizide
* Drug: Placebo for Sitagliptin
* Drug: Placebo for Glipizide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has type 2 diabetes mellitus Has moderate or severe renal insufficiency Exclusion Criteria: Has type 1 diabetes mellitus or a history of ketoacidosis Is on a new weight loss program Has active liver disease Is on dialysis or is likely to need dialysis during the study

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Sitagliptin + Placebo for Glipizide | Drug: Sitagliptin<br>* Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily<br>* Other names: Januvia;Drug: Placebo for Glipizide<br>* Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily<br>|
| Active Comparator: Glipizide<br>Glipizide + Placebo for Sitagliptin | Drug: Glipizide<br>* Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)<br>* Other names: Glucotrol;Drug: Placebo for Sitagliptin<br>* Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 | A1C represents percentage of glycosylated hemoglobin. | Baseline to Week 54 | 
| Percentage of Participants With Hypoglycemic Events | Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy. | Baseline up to 28 days following the last dose of study therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 |  | Baseline to Week 54 | 
| Change From Baseline in Body Weight at Week 54 |  | Baseline to Week 54 |