Use of Sitagliptin to Decrease Microalbuminuria

NCT02048904 | Terminated Phase 4 Results

• 1 other identifier: 1207397
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes; Microalbuminuria

Keywords

microalbuminuria; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Microalbuminuria Level

  Decrease in microalbuminuria level

  Six months

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR

100 mg/day for 3 months

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

1 pill/day for 3 months

Drug: Placebo

Interventions

Sitagliptin DRUG

Sitagliptin 100 mg/day for 3 months

Also known as: Januvia

Sitagliptin

Placebo DRUG

Placebo 1 pill/day for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia: Diabetes Center

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Study was terminated during the enrollment period due to difficulties at the study site. 65 participants had completed study by time of study termination.No data were collected or analyzed.

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Missouri

lastrag@health.missouri.edu

573-882-2273 lastrag@healt

Study Officials

• Guido Lastra Gonzalez, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 10, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-06

Locations

US (1)