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

NCT02330406 | Completed Phase 4 DMC

• 1 other identifier: ICE_2014_01R
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dipeptidyl-Peptidase 4 Inhibitors; LDL Cholesterol; Glycosylated Hemoglobin; Diabetes Mellitus; Coronary Disease

Keywords

Dipeptidyl-Peptidase 4 Inhibitors; LDL Cholesterol; Glycosylated Hemoglobin; Diabetes Mellitus; Coronary Disease

Outcome Measures

Primary Outcomes (2)

• Change in low-density lipoprotein cholesterol

  52-weeks

• Change in glycated hemoglobin

  52-weeks

Secondary Outcomes (22)

• Change in fasting glucose

  52-weeks

• Change in fasting insulin

  52-weeks

• Change in 1.5-Anhydro-D-glucitol

  52-weeks

• Change in C peptide

  52-weeks

• Change in total cholesterol, triglyceride, non high dencisty lipoprotein cholesterol

  52-weeks

Study Arms (2)

Anagliptin

ACTIVE COMPARATOR

Anagliptin 100 mg bid for 52 weeks. Can increase to 200 mg bid if needed.

Drug: Anagliptin

Sitagliptin

ACTIVE COMPARATOR

Sitagliptin 50 mg qd for 52 weeks. Can increase to 100 mg qd if needed

Drug: Sitagliptin

Interventions

Anagliptin DRUG

Suiny 100 mg

Also known as: Suiny

Anagliptin

Sitagliptin DRUG

Januvia 50 mg Glactiv 50 mg

Also known as: Januvia, Glactiv

Sitagliptin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical Effectiveness, Japan: lead

Study Sites (1)

Department of Cardiovascular Medicine, Tomishiro Central Hospital

Tomishiro, Okinawa, 901-0243, Japan

Location

Related Publications (4)

• 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.

  PMID: 32539832 DERIVED

• 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.

  PMID: 31733647 DERIVED

• 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.

  PMID: 31189978 DERIVED

• 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.

  PMID: 29435776 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Disease

Interventions

anagliptin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shinichiro Ueda, MD, PhD

  Professor of Medicine, Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 5, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

JP (1)