Use of Sitagliptin to Decrease Microalbuminuria

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 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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes; Microalbuminuria
• Intervention / Treatment: Drug: Sitagliptin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia: Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sitagliptin; 100 mg/day for 3 months	Drug: Sitagliptin; Sitagliptin 100 mg/day for 3 months; Other Names: Januvia
Placebo Comparator: Placebo; 1 pill/day for 3 months	Drug: Placebo; Placebo 1 pill/day for 3 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Guido Lastra Gonzalez, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: type 2 diabetes; microalbuminuria
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 1207397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided