Type 2 DiabetesPhase 4NCT02301806
Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
A Phase 4 study testing dieting, Sitagliptin and Glimepiride in people with Type 2 Diabetes, run by Dokkyo Medical University at 2 sites in Japan.
Trial summary
To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- dieting, Sitagliptin and Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesJapan
- Study dates
- Jan 2015to Jul 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent before any study specific procedures
- Type II diabetes who have inadequate glycaemic control (6.5%≦HbA1c<9.0%)
- Age from 20 to 80 years old
- No history of using any antihyperglycemic drugs
- No history of cardiovascular complications
- No treatment or treatment with stable doses of lipid-lowering, antihypertensive, and antiplatelet agents for at least 3 months prior to randomization
- 4.5 % ≤ fasting FMD at baseline < 8.0 %
Who cannot join
- ・Type I diabetes
- Pregnancy
- Liver disease (hepatic enzymes more than three times the upper limit of normal ranges)
- Impairared kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
- Cigarette smokers
- Contraindications to glimepiride and sitagliptin
- Active proliferative diabetic retinopathy
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Dokkyo Medical University
Mibu, Tochigo, 321-0293
Yoshimasa Aso, MD, 81-282-86-1111, yaso@dokkyomed.ac.jp
Yoshimasa Aso, MD
- Recruiting
Study site
Mibu
About this study
Official title: A Randomized, Prospective, Parallel Design Study to Compare the Effectiveness of Sitagliptin Versus Glimepiride on Endothelial Dysfunction During an Oral Glucose Loading in Drug Naive Patients With Type 2 Diabetes.
To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM.
To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.
Read the detailed description
Acute and chronic improvement of endothelial function is expected through the pleiotropic effect of DPP-4 inhibitors. A randomized, prospective, open-labeled, parallel design. The duration of treatments with sitagliptin or glimepiride is 12 weeks. The number of study centers is a single (Dokkyo Medical University Hospital). Participants will be randomized into the two treatment groups; (a) 50mg sitagliptin (N=15) and (b) 1mg glimepiride (N=15).
Anti-Hyperglycemic effect is expected to be similar according to our study
- Conditions
- Type 2 Diabetes
- Being tested
- dieting, Sitagliptin, Glimepiride
- 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.
dietingOther
SitagliptinDrug
sitagliptin 50 mg tablet by mouth 12 weeks
GlimepirideDrug
glimepiride 1 mg tablet by mouth 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | sitagliptin 50 mg tablet by mouth 12 weeks Receives: Other: dieting; Drug: Sitagliptin |
| Glimepiride | Active comparator | glimepiride 1 mg tablet by mouth 12 weeks Receives: Other: dieting; Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function during the OGTT evaluated by flow-mediated vasodilatation (FMD). The change is defined as below, assuming the peak value and changes of FMD will be observed at t=60 min.
Measured: 12 weeks
Secondary outcomes (1)
Change in endothelial function during OGTT* evaluated by endo-PAT. Change in endothelial function after 12-week treatment at the fasting state evaluated by endo-PAT and FMD.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokkyo Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Yoshimasa Aso, Dokkyo Medical University
- Investigators
- Yoshimasa Aso, Principal investigator, Dokkyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301806
- Sponsor's protocol ID
- C-282-02
- Status last verified
- Feb 2016
- First submitted
- 22 Nov 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Parallel Design Study to Compare the Effectiveness of Sitagliptin Versus Glimepiride on Endothelial Dysfunction During an Oral Glucose Loading in Drug Naive Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT02301806
- Acronym / sponsor ID
- C-282-02
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dokkyo Medical UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Nov 2014 (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.
To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM.
To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.
Detailed description
Acute and chronic improvement of endothelial function is expected through the pleiotropic effect of DPP-4 inhibitors. A randomized, prospective, open-labeled, parallel design. The duration of treatments with sitagliptin or glimepiride is 12 weeks. The number of study centers is a single (Dokkyo Medical University Hospital). Participants will be randomized into the two treatment groups; (a) 50mg sitagliptin (N=15) and (b) 1mg glimepiride (N=15).
Anti-Hyperglycemic effect is expected to be similar according to our study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Other: dieting, Drug: Sitagliptinsitagliptin 50 mg tablet by mouth 12 weeks |
| Glimepiride | Active comparator | Other: dieting, Drug: Glimepirideglimepiride 1 mg tablet by mouth 12 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent before any study specific procedures
- Type II diabetes who have inadequate glycaemic control (6.5%≦HbA1c<9.0%)
- Age from 20 to 80 years old
- No history of using any antihyperglycemic drugs
- No history of cardiovascular complications
Key exclusion criteria (7 listed)
- ・Type I diabetes
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 |
|---|---|---|
| dieting | Other | Glimepiride, Sitagliptin |
| Sitagliptinsitagliptin 50 mg tablet by mouth 12 weeks | Drug | Sitagliptin |
| Glimepirideglimepiride 1 mg tablet by mouth 12 weeks | Drug | Glimepiride |
Primary outcome
Change in endothelial function during the OGTT evaluated by flow-mediated vasodilatation (FMD). The change is defined as below, assuming the peak value and changes of FMD will be observed at t=60 min.
Time frame: 12 weeks
1 secondary outcome
Change in endothelial function during OGTT* evaluated by endo-PAT. Change in endothelial function after 12-week treatment at the fasting state evaluated by endo-PAT and FMD.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Yoshimasa Aso principal investigator
Dokkyo Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dieting, Sitagliptin and Glimepiride in people with Type 2 Diabetes, run by Dokkyo Medical University at 2 sites 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 7 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yoshimasa Aso, MD (81-282-86-1111, yaso@dokkyomed.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function during the OGTT evaluated by flow-mediated vasodilatation (FMD). The change is defined as below, assuming the peak value and changes of FMD will be observed at t=60 min. (time frame: 12 weeks). 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 17 Feb 2016.