SGLT-2 InhibitorsPhase 4NCT02768220
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
A Phase 4 study testing empagliflozin and linagliptin in people with SGLT-2 Inhibitors and Advanced Glycation End Products, run by Northwell Health.
Trial summary
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SGLT-2 Inhibitors, Advanced Glycation End Products, Diabetes
- What is being tested?
- empagliflozin and linagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- T2DM
- Age ≥ 18
- glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
- A1C ≥ 7% any higher limit
- SLGT-2 inhibitor naïve
- On stable doses of current medications for at least 3 months.
Who cannot join
- Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- Contraindications to background therapy according to the local label
- Any uncontrolled endocrine disorder except type 2 diabetes
- Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial
- o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
About this study
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.
Read the detailed description
Single-center open-label multiple dose randomized two period cross-over study.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.
Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.
AGE levels will be measured by Elisa.
- Conditions
- SGLT-2 Inhibitors, Advanced Glycation End Products, Diabetes
- Being tested
- empagliflozin, linagliptin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Also called Jardiance
Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels
linagliptinDrug
Also called tradjenta
Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin | Active comparator | Eligible patients were randomized to receive linagliptin 5mg daily for 30 days. Receives: Drug: empagliflozin |
| Empagliflozin | Experimental | Eligible patients were randomized empagliflozin 25mg daily for 30 days. Receives: Drug: linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AGE levels
Measurement of serum and urinary AGE levels
Measured: 30 days
Secondary outcomes (2)
Change in blood pressure
measurement of BP
Measured: 30 days
Change in weight
measurement of weight
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Dec 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SGLT-2 InhibitorsStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Messer, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768220
- Sponsor's protocol ID
- SGLT2-AGE
- Status last verified
- Feb 2018
- First submitted
- 9 May 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
- ClinicalTrials.gov ID
- NCT02768220
- Acronym / sponsor ID
- SGLT2-AGE
- Conditions
- SGLT-2 Inhibitors, Advanced Glycation End Products, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.
Detailed description
Single-center open-label multiple dose randomized two period cross-over study.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.
Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.
AGE levels will be measured by Elisa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin | Active comparator | Drug: empagliflozinEligible patients were randomized to receive linagliptin 5mg daily for 30 days. |
| Empagliflozin | Experimental | Drug: linagliptinEligible patients were randomized empagliflozin 25mg daily for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- T2DM
- Age ≥ 18
- glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
- A1C ≥ 7% any higher limit
- SLGT-2 inhibitor naïve
Key exclusion criteria (8 listed)
- Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- Contraindications to background therapy according to the local label
- Any uncontrolled endocrine disorder except type 2 diabetes
- Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial
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 |
|---|---|---|
| empagliflozinAlso: JardianceTest to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels | Drug | Linagliptin |
| linagliptinAlso: tradjentaTest to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels | Drug | Empagliflozin |
Primary outcome
Change in AGE levels
Time frame: 30 days
Measurement of serum and urinary AGE levels
2 secondary outcomes
Change in blood pressure
Time frame: 30 days
Change in weight
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing empagliflozin and linagliptin in people with SGLT-2 Inhibitors and Advanced Glycation End Products, run by Northwell Health.
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 8 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: withdrawn, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 AGE levels (time frame: 30 days). 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 15 Feb 2018.