Use of Sitagliptin to Decrease Microalbuminuria

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02048904
• Other study ID #: 1207397
• Status: Terminated
• Phase: Phase 4
• First received: January 27, 2014
• Last updated: September 29, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2
• Microalbuminuria
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
Sitagliptin 100 mg/day for 3 months
• Placebo
Placebo 1 pill/day for 3 months

Locations

Country	Name	City	State
United States	University of Missouri-Columbia: Diabetes Center	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microalbuminuria level	Decrease in microalbuminuria level	Six months	No