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Dipeptidyl-Peptidase 4 InhibitorsPhase 4REASONNCT02330406

Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial

A Phase 4 study testing Anagliptin and Sitagliptin in people with Dipeptidyl-Peptidase 4 Inhibitors and LDL Cholesterol, run by Institute for Clinical Effectiveness, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Anagliptin and Sitagliptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
1 siteJapan
Study dates
Apr 2015to Mar 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes with cardiovascular risk factors (*) who treated with diet, exercise or antidiabetic medications
  • Patients who were treated with statins for 8 weeks or longer
  • Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
  • Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %
  • () cardiovascular risk factors were any of following conditions
  • Presence of stenosis (>=25%) or plaque on the previous coronary angiography or coronary CT
Show all 14Show fewer
  • Presence of coronary calcification on the previous coronary CT
  • History of acute coronary syndrome
  • History of percutaneous coronary intervention or coronary artery bypass graft
  • History of stroke (ischemic stroke or hemorrhagic stroke)
  • History of transient ischemic attack
  • History of peripheral artery diseases or aortic disorders
  • Ankle-Brachial Index (AMI) equal to or less than 0.9 in the past measurement
  • Presence of carotid artery plaque (including Max IMT >=1.1mm) on carotid ultrasonography in the past

Who cannot join

  • Patients with type 1 diabetes
  • Patients with triglyceride equal to or greater than 400 mg/dL in the previous fasting measurements
  • Patients with pregnancy, possible pregnancy, or on breast-feeding
  • Patients with severe infections, perioperative status, or severe trauma
  • Patients with renal dysfunction (creatinine >= 2.4 mg/dl for men, >= 2.0 mg/dl for women)
  • Patients who were received glucagon-like peptide-1receptor agonists
  • Patients whom physician in charge considered inappropriate for the study

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Department of Cardiovascular Medicine, Tomishiro Central Hospital

    Tomishiro, Okinawa, 901-0243

Other trials in Japan

About this study

Official title: Effect of Anagliptin and Sitagliptin on Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes and Cardiovascular Risk Factors: Randomized Controlled Trial

The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.

Read the detailed description

Diabetes is a significant cause of cardiovascular and cerebrovascular events. Especially, diabetic patients with cardiovascular risk factors were significantly higher risk for cardiovascular and cerebrovasculara event. Therefore, several medical management strategies including anti-diabetic medications and statins were considered for those patients. However, in spite of such treatment, still many patients have cardiovascular and cerebrovascular events. One of the hypothesis is the residual risk such as elevated low-density lipoprotein cholesterol (LDLC) even with statin therapy. Anagliptin, one of the dipeptidyl peptidase-4 (DPP4) inhibiors, was reported to reduce LDLC and may have pontential to decrease the cardiovascular and cerebrovascular risk for such patients on statins. We, thus, conduct a randomized controlled trial to compare Anagliptin or Sitagliptin in terms of change of LDLC for 52 weeks as well as glycemic control.

Being tested
Anagliptin, Sitagliptin
Keywords
Dipeptidyl-Peptidase 4 Inhibitors, LDL Cholesterol, Glycosylated Hemoglobin, Diabetes Mellitus, Coronary Disease
Medical subject headings
Diabetes Mellitus, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnagliptinDrug

    Also called Suiny

    Suiny 100 mg

  • SitagliptinDrug

    Also called Januvia, Glactiv

    Januvia 50 mg Glactiv 50 mg

Study groups in NCT02330406
Study groupRoleWhat they receive
AnagliptinActive comparatorAnagliptin 100 mg bid for 52 weeks. Can increase to 200 mg bid if needed.
Receives: Drug: Anagliptin
SitagliptinActive comparatorSitagliptin 50 mg qd for 52 weeks. Can increase to 100 mg qd if needed
Receives: Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in low-density lipoprotein cholesterol

    Measured: 52-weeks

  2. Change in glycated hemoglobin

    Measured: 52-weeks

Secondary outcomes (22)

  1. Change in fasting glucose

    Measured: 52-weeks

  2. Change in fasting insulin

    Measured: 52-weeks

  3. Change in 1.5-Anhydro-D-glucitol

    Measured: 52-weeks

  4. Change in C peptide

    Measured: 52-weeks

  5. Change in total cholesterol, triglyceride, non high dencisty lipoprotein cholesterol

    Measured: 52-weeks

  6. Change in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein E

    Measured: 52-weeks

  7. Change in Apolipoprotein B48

    Measured: 52-weeks

  8. Change in small dense low density lipoprotein

    Measured: 52-weeks

  9. Change in high sensitivity C-reactive protein

    Measured: 52-weeks

  10. Change in interleukin-6

    Measured: 52-weeks

  11. Change in cholesterol absorption marker (campesterol; sitosterol)

    Measured: 52-weeks

  12. Change in cholesterol synthesis marker (lathosterol)

    Measured: 52-weeks

  13. Change in high molecular weight adiponectin

    Measured: 52-weeks

  14. Change in ratio of albumin and creatinine in urine

    Measured: 52-weeks

  15. Progression, unchange, remission rate of microalbumin and macroalbumin in urine

    Measured: 52-weeks

  16. Change in estimated glomerular filtration rate

    Measured: 52-weeks

  17. Change in glycated hemoglobin stratified by body mass index and waist circumference

    Measured: 52-weeks

  18. Correlation between glycated hemoglobin and body mass index or waist circumference

    Measured: 52-weeks

  19. Change in intima-media thickness or flow mediated dilation

    Measured: 52-weeks

  20. Change in postprandial glucose, insulin and activated glucagon-like peptide-1

    Measured: 52-weeks

  21. Change in lipid profile and molecular size measured

    Measured: 52-weeks

  22. Change in fatty acid fraction

    Measured: 52-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJan 2018
  4. Study completionMar 2019

Resources

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
Investigator, Outcomes assessor
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330406
Sponsor's protocol ID
ICE_2014_01R
Acronym
REASON
Status last verified
Aug 2019
First submitted
30 Dec 2014
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Furuhashi M, Sakuma I, Morimoto T, Higashiura Y, Sakai A, Matsumoto M, Sakuma M, Shimabukuro M, Nomiyama T, Arasaki O, Node K, Ueda S. Treatment with anagliptin, a DPP-4 inhibitor, decreases FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy. Cardiovasc Diabetol. 2020 Jun 15;19(1):89. doi: 10.1186/s12933-020-01061-0.

    PubMed 32539832

  • Chihara A, Tanaka A, Morimoto T, Sakuma M, Shimabukuro M, Nomiyama T, Arasaki O, Ueda S, Node K. Differences in lipid metabolism between anagliptin and sitagliptin in patients with type 2 diabetes on statin therapy: a secondary analysis of the REASON trial. Cardiovasc Diabetol. 2019 Nov 16;18(1):158. doi: 10.1186/s12933-019-0965-3.

    PubMed 31733647

  • Morimoto T, Sakuma I, Sakuma M, Tokushige A, Natsuaki M, Asahi T, Shimabukuro M, Nomiyama T, Arasaki O, Node K, Ueda S. Randomized Evaluation of Anagliptin vs Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) Trial: A 52-week, open-label, randomized clinical trial. Sci Rep. 2019 Jun 12;9(1):8537. doi: 10.1038/s41598-019-44885-x.

    PubMed 31189978

  • Ueda S, Shimabukuro M, Arasaki O, Node K, Nomiyama T, Morimoto T. Effect of Anagliptin and Sitagliptin on Low-Density Lipoprotein Cholesterol in Type 2 Diabetic Patients with Dyslipidemia and Cardiovascular Risk: Rationale and Study Design of the REASON Trial. Cardiovasc Drugs Ther. 2018 Feb;32(1):73-80. doi: 10.1007/s10557-018-6776-z.

    PubMed 29435776

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anagliptin and Sitagliptin in people with Dipeptidyl-Peptidase 4 Inhibitors and LDL Cholesterol, run by Institute for Clinical Effectiveness, Japan 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 14 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 low-density lipoprotein cholesterol (time frame: 52-weeks). The study lists 2 primary outcomes in all. 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 NCT02330406, which also lists 4 linked publications.

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 28 Aug 2019.

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