Use of Sitagliptin to Decrease Microalbuminuria

Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 75
Start Date:January 2014

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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

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.

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.

Inclusion Criteria:

- Albumin/creatinine ratio between 30-299 mg/dl.

- 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 OCP, 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 GLP-1 agonist for at least 4 months before
the study start.

- Psychiatric condition that would prevent subject from following directions. Per PI
We found this trial at
Columbia, MO
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