Microalbuminuria, Type 2 Diabetes
Conditions
Keywords
microalbuminuria, type 2 diabetes
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.
Interventions
DRUGSitagliptin
Sitagliptin 100 mg/day for 3 months
DRUGPlacebo
Placebo 1 pill/day for 3 months
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microalbuminuria Level | Six months | Decrease in microalbuminuria level |
Countries
United States
Participant flow
Recruitment details
Total enrollment at time of termination of study was 142 participants. However, study was terminated during the enrollment period due to difficulties at the study site. All data collected from participants remains untabulated and no analysis is expected.
Pre-assignment details
65 participants had completed study by time of study termination.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin or Placebo 100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 70 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18 - 75 years | — Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 142 |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
Primary
Change in Microalbuminuria Level
Decrease in microalbuminuria level
Time frame: Six months
Population: Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.