Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic ComplicationsPhase 4NCT02528019
Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors
A Phase 4 study testing DPP-4 inhibiotors, SGLT2 inhibitors and Glimepiride in people with Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications, run by Kurume University at 1 site in Japan.
Trial summary
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
- What is being tested?
- DPP-4 inhibiotors, SGLT2 inhibitors and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2015to Aug 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetic patients
- Must be able to swallow tablets
- never received DPP-4 inhibitors or SGLT2 inhibitors
Who cannot join
- uncontrolled diabetes (fasting plasma glucose>200 mg/dL)
- receiving insulin therapy
- hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
- inflammatory disorders
- neoplastic disorders
- recent (<3months) acute coronary syndrome and stroke
- any acute infection
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kurume University Hospital
Kurume, 830-0011
Nobuhiro Tahara, MD, PhD, +81-942-31-7580, ntahara@med.kurume-u.ac.jp
Sho-ichi Yamagishi, MD, PhD, +81-942-31-7562
About this study
Official title: Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.
- Being tested
- DPP-4 inhibiotors, SGLT2 inhibitors, Glimepiride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP-4 inhibiotorsDrug
SGLT2 inhibitorsDrug
GlimepirideDrug
| Study group | Role | What they receive |
|---|---|---|
| DPP-4 inhibitors | Active comparator | sitagliptin (25-100mg daily), vildagliptin (50-100mg daily), alogliptin (12.5-25mg daily), linagliptin (2.5-5mg daily), teneligliptin (20-40mg), anagliptin (100-200mg daily), saxagliptin (2.5-5mg daily) or trelagliptin (50-100mg weekly) Receives: Drug: DPP-4 inhibiotors |
| SGLT2 inhibitors | Active comparator | ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily) Receives: Drug: SGLT2 inhibitors |
| Glimepiride | Active comparator | glimepiride (0.5-8mg daily) Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Measured: 6 months of treatment
Secondary outcomes (3)
Change from baseline in subcutaneous and visceral fat volume
Measured: 6 months of treatment
Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
Measured: 6 months of treatment
Change from baseline in circulating inflammatory markers
Measured: 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic ComplicationsStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuhiro Tahara, Kurume University
- Investigators
- Nobuhiro Tahara, MD, PhD, Study chair, Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528019
- Sponsor's protocol ID
- Anti-athero
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Bekki M, Tahara N, Tahara A, Igata S, Honda A, Sugiyama Y, Nakamura T, Sun J, Kumashiro Y, Matsui T, Fukumoto Y, Yamagishi SI. Switching Dipeptidyl Peptidase-4 Inhibitors to Tofogliflozin, a Selective Inhibitor of Sodium-Glucose Cotransporter 2 Improve Arterial Stiffness Evaluated by Cardio-Ankle Vascular Index in Patients with Type 2 Diabetes: A Pilot Study. Curr Vasc Pharmacol. 2019;17(4):411-420. doi: 10.2174/1570161116666180515154555.
PubMed 29766812
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT02528019
- Acronym / sponsor ID
- Anti-athero
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Aug 2015 (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.
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPP-4 inhibitors | Active comparator | Drug: DPP-4 inhibiotorssitagliptin (25-100mg daily), vildagliptin (50-100mg daily), alogliptin (12.5-25mg daily), linagliptin (2.5-5mg daily), teneligliptin (20-40mg), anagliptin (100-200mg daily), saxagliptin (2.5-5mg daily) or trelagliptin (50-100mg weekly) |
| SGLT2 inhibitors | Active comparator | Drug: SGLT2 inhibitorsipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily) |
| Glimepiride | Active comparator | Drug: Glimepirideglimepiride (0.5-8mg daily) |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetic patients
- Must be able to swallow tablets
- never received DPP-4 inhibitors or SGLT2 inhibitors
Key exclusion criteria (7 listed)
- uncontrolled diabetes (fasting plasma glucose>200 mg/dL)
- receiving insulin therapy
- hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
- inflammatory disorders
- neoplastic disorders
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 |
|---|---|---|
| DPP-4 inhibiotors | Drug | DPP-4 inhibitors |
| SGLT2 inhibitors | Drug | SGLT2 inhibitors |
| Glimepiride | Drug | Glimepiride |
Primary outcome
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Time frame: 6 months of treatment
3 secondary outcomes
Change from baseline in subcutaneous and visceral fat volume
Time frame: 6 months of treatment
Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
Time frame: 6 months of treatment
Change from baseline in circulating inflammatory markers
Time frame: 6 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 29766812Bekki M, Tahara N, Tahara A, Igata S, Honda A, Sugiyama Y, Nakamura T, Sun J, Kumashiro Y, Matsui T, Fukumoto Y, Yamagishi SI. Switching Dipeptidyl Peptidase-4 Inhibitors to Tofogliflozin, a Selective Inhibitor of Sodium-Glucose Cotransporter 2 Improve Arterial Stiffness Evaluated by Cardio-Ankle Vascular Index in Patients with Type 2 Diabetes: A Pilot Study. Curr Vasc Pharmacol. 2019;17(4):411-420. doi: 10.2174/1570161116666180515154555.
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.
Nobuhiro Tahara, MD, PhD study chair
Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
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 DPP-4 inhibiotors, SGLT2 inhibitors and Glimepiride in people with Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications, run by Kurume University at 1 site in Japan.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Aug 2015. 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 Japan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nobuhiro Tahara, MD, PhD (+81-942-31-7580, ntahara@med.kurume-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index (time frame: 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528019, which also lists 1 linked publication.
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 19 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.