Use of Sitagliptin to Decrease Microalbuminuria

Study Overview
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Brief Summary
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The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse. This study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it will reduce protein levels in their urine. Protein levels in the urine are a marker of the severity of kidney disease.

Detailed Description
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The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an ACE inhibitor or ARB. However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.

Official Title
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Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease

Conditions
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Type 2 Diabetes, Microalbuminuria

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Albumin/creatinine ratio between 30-299 mg/dl. type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%. Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three months prior and during the trial. Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more. Age between 18-75 years old. For women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (OCP), intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start. Exclusion Criteria: Pregnancy. GFR less than 60 mL/min/73m2. Have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to Visit 1. Advanced liver disease. Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least 4 months before the study start. Psychiatric condition that would prevent subject from following directions. Per PI discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Sitagliptin<br>100 mg/day for 3 months | Drug: Sitagliptin<br>* Sitagliptin 100 mg/day for 3 months<br>* Other names: Januvia;|
| Placebo Comparator: Placebo<br>1 pill/day for 3 months | Drug: Placebo<br>* Placebo 1 pill/day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Microalbuminuria Level | Decrease in microalbuminuria level | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microalbuminuria, type 2 diabetes