Type 2 DiabetesPhase 4NCT02048904
Use of Sitagliptin to Decrease Microalbuminuria
A Phase 4 study testing Sitagliptin in people with Type 2 Diabetes and Microalbuminuria, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Microalbuminuria
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia: Diabetes Center
Columbia, Missouri, 65212
About this study
Official title: Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Microalbuminuria
- Being tested
- Sitagliptin, Placebo
- Keywords
- microalbuminuria, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin 100 mg/day for 3 months
PlaceboDrug
Placebo 1 pill/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | 100 mg/day for 3 months Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | 1 pill/day for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microalbuminuria Level
Decrease in microalbuminuria level
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJun 2016
Why it stopped: Original Principal Investigator left institution. No data analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Lastra Gonzalez, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048904
- Sponsor's protocol ID
- 1207397
- Status last verified
- Jun 2017
- First submitted
- 27 Jan 2014
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease
- ClinicalTrials.gov ID
- NCT02048904
- Acronym / sponsor ID
- 1207397
- Conditions
- Type 2 Diabetes, Microalbuminuria
- Keywords
- microalbuminuria, type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original Principal Investigator left institution. No data analyzed.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: Sitagliptin100 mg/day for 3 months |
| Placebo | Placebo comparator | Drug: Placebo1 pill/day for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin 100 mg/day for 3 months | Drug | Sitagliptin |
| PlaceboPlacebo 1 pill/day for 3 months | Drug | Placebo |
Primary outcome
Change in Microalbuminuria Level
Time frame: Six months
Decrease in microalbuminuria level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Lastra Gonzalez, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin in people with Type 2 Diabetes and Microalbuminuria, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Microalbuminuria Level (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.