UMIN-CTR Clinical Trial

Basic information
Public title	Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study
Acronym	EVOLB study
Scientific Title	Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study
Scientific Title:Acronym	EVOLB study
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of empagliflozin and omarigliptin on beta-cell function in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing the two groups of change in beta-cell function (Insulin Secretion-Sensitivity Index-2; ISSI-2) over the 24-week treatment period.
Key secondary outcomes	Change in next items between baseline, 24 weeks of treatment, and 4 weeks of washout. 1. HbA1c 2. Glycated albumin 3. Fasting plasma glucose 4. Plasma glucose post 2h 75g-OGTT 5. Serum creatinine 6. eGFR based on serum creatinine 7. Urine albumin-creatinine ratio 8. Serum cystatin C 9. eGFR based on serum cystatin C 10. Triglyceride 11. HDL-cholesterol 12. LDL-cholesterol 13. Systolic blood pressure 14. Diastolic blood pressure 15. Pulse rate 16. Body weight 17. Waist circumference 18. Body composition 19. ISSI-2 20. delta-Ins0-120/delta-Glu0-120 x Matsuda index 21. Insulinogenic index 22. Matsuda index 23. HOMA2-IR 24. Fasting plasma glucagon 25. Plasma glucagon post 2h 75g-OGTT 26. Change in plasma glucagon during 2h 75g-OGTT 27. Medication compliance 28. Hypoglycemic events rates 29. Other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin 10mg/day for 24 weeks and washout for 4 weeks.
Interventions/Control_2	Omarigliptin 25mg/week for 24 weeks and washout for 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Age between 20 and 85 years 2. Diabetes duration =<10 years 3. Both gender 4. Treated with diet +/- exercise therapy 5. Treated with oral hypoglycemic agents 6. Under stable diabetes treatment for over eight weeks 7. Fasting plasma glucose level between 70 mg/dL and 180 mg/dL 8. HbA1c =<10.0%
Key exclusion criteria	1. Use of insulin, DPP-4 inhibitor, GLP-1 receptor agonist, or SGLT-2 inhibitor 2. Type 1 diabetes or secondary forms of diabetes 3. Renal dysfunction (eGFR <35 ml/min/1.73m2) at screening 4. Hepatic dysfunction (AST and/or ALT >3x upper limit of normal) 5. Experiencing cardiovascular event within six month 6. Malignant neoplasm 7. Use of systemic steroid 8. Severe infection or injury 9. Hypersensitivity to empagliflozin or omarigliptin 10. Pregnant or willing to be pregnant during this study 11. Unable to obtain informed consent to this study 12. Unable to maintain compliance during this study 13. Expectation of extremely hyperglycemia during empagliflozin or omarigliptin washout period.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoaki Middle name Last name Akiyama
Organization	Yokohama City University Medical Center
Division name	Endocrinology and Diabetes
Zip code	2320024
Address	4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
TEL	045-261-5656
Email	tomoakikunda@hotmail.com

Public contact
Name of contact person	1st name Tomoaki Middle name Last name Akiyama
Organization	Yokohama City University Medical Center
Division name	Endocrinology and Diabetes
Zip code	232-0024
Address	4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
TEL	045-261-5656
Homepage URL
Email	tomoakikunda@hotmail.com

Sponsor
Institute	Yokohama City University Medical Center Department of Endocrinology and Diabetes
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Medical Ethics Committee for Humans
Address	3-9 FukuuraKanazawa-ku, Yokohama, Kanagawa, Japan
Tel	+81-45-370-7627
Email	rinri@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 27 Day
Date of IRB	2018 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 26 Day
Last modified on	2020 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038639