Use of Sitagliptin to Decrease Microalbuminuria

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Marianna Touza, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT02048904
First received: January 27, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Microalbuminuria in Type Two Diabetes
Drug: Sitagliptin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Decrease in microalbuminuria level [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin
100 mg/day for 3 months
Drug: Sitagliptin
Placebo Comparator: Placebo
1 pill/day for 3 months
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 discretion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048904

Locations
United States, Missouri
University of Missouri-Columbia: Diabetes Center Recruiting
Columbia, Missouri, United States, 65212
Contact: Marianna G Touza, M.D.    573-882-3267    touzam@health.missouri.edu   
Contact: Tracey A Summerfield-Littell, M.Ed.    573-884-1222    summerfieldt@health.missouri.edu   
Principal Investigator: Mariana G Touza, M.D.         
Sub-Investigator: Michael J Gardner, M.D.         
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Marianna Touza, M.D., University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02048904     History of Changes
Other Study ID Numbers: 1207397
Study First Received: January 27, 2014
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
microalbuminuria
type two diabetes

Additional relevant MeSH terms:
Urination Disorders
Albuminuria
Proteinuria
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014