UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033902
Receipt number R000038639
Scientific Title Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study
Date of disclosure of the study information 2018/12/01
Last modified on 2020/05/27 10:53:50

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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 or person

Institute

Yokohama City University Medical Center
Department of Endocrinology and Diabetes

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name