Use of Sitagliptin to Decrease Microalbuminuria
Primary Purpose
Type 2 Diabetes, Microalbuminuria
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring microalbuminuria, type 2 diabetes
Eligibility Criteria
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.
Sites / Locations
- University of Missouri-Columbia: Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sitagliptin
Placebo
Arm Description
100 mg/day for 3 months
1 pill/day for 3 months
Outcomes
Primary Outcome Measures
Change in Microalbuminuria Level
Decrease in microalbuminuria level
Secondary Outcome Measures
Full Information
NCT ID
NCT02048904
First Posted
January 27, 2014
Last Updated
July 11, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02048904
Brief Title
Use of Sitagliptin to Decrease Microalbuminuria
Official Title
Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Original Principal Investigator left institution. No data analyzed.
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Microalbuminuria
Keywords
microalbuminuria, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
100 mg/day for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 pill/day for 3 months
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin 100 mg/day for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 pill/day for 3 months
Primary Outcome Measure Information:
Title
Change in Microalbuminuria Level
Description
Decrease in microalbuminuria level
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Lastra Gonzalez, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia: Diabetes Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Use of Sitagliptin to Decrease Microalbuminuria
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