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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033902
Receipt No. 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 2019/02/21

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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
Middle name
Last name Yoshinobu Kondo
Organization Yokohama City University Medical Center
Division name Endocrinology and Diabetes
Zip code
Address 4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
TEL 045-261-5656
Email kondoycu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kondo
Organization Yokohama City University Medical Center
Division name Endocrinology and Diabetes
Zip code
Address 4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
TEL 045-261-5656
Homepage URL
Email kondoycu@gmail.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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
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
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.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


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