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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027614
Receipt No. R000031631
Scientific Title Effects of liraglutide and empagliflozin add-on to insulin therapy in patients with type 2 diabetes: a randomized controlled study
Date of disclosure of the study information 2017/06/03
Last modified on 2019/05/11

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Basic information
Public title Effects of liraglutide and empagliflozin add-on to insulin therapy in patients with type 2 diabetes: a randomized controlled study
Acronym ELLENA-IT study
Scientific Title Effects of liraglutide and empagliflozin add-on to insulin therapy in patients with type 2 diabetes: a randomized controlled study
Scientific Title:Acronym ELLENA-IT study
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to compare the effect of GLP-1 receptor agonist liraglutide and SGLT-2 inhibitor empagliflozin on glucose metabolism in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparing the two groups of change in HbA1c over the 24-week treatment period.

Key secondary outcomes Change in next items between baseline and 24 weeks of treatment.

1.HOMA2-%beta (%)
2.HOMA2-IR
3.CPR-index
4.Glycated albumin
5.Fasting plasma glucose (mg/dL)
6.Self-measured postprandial glucose (mg/dL)
7.Systolic blood pressure(mmHg)
8. Diastolic blood pressure(mmHg)
9.Pulse rate
10.Lipid profile
11.Serum creatinine(mg/dL),eGFR (ml/min/1.73m2),cystatinC(mg/L)
12.UA(mg/dL)
13.AST,ALT,gamma-GTP
14.Urine albumin/creatinine ratio (mg/g・Cr)
15.Urine natrium/creatinine ratio
16.Insulin dose(units/day)
17.Body weight (kg)
18.Waist circumference (cm)
19.Fat mass (kg)
20.Body fat percentage(%)
21.Lean tissue mass (kg)
22.Hypoglicemic events
23.Medication compliance(%)
24.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 Liraglutide 0.9mg/day,24 weeks

Starting at 0.3mg once daily with weekly increments of 0.3mg,reaching a final daily dose of 0.9mg.
Interventions/Control_2 Empagliflozin 10mg/day,24 weeks

Provided that from 12 weeks onward,if FPG is>=180mg/dL or HbA1c>=8.5%,the dose of empagliflozin is increased up to 25mg/day.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1)Outpatients with type 2 diabetes ; age between 20 and 80 years
(2)Both gender
(3)Patients without GLP-1RA,SGLT2i,DPP4i more than 8 weeks before intervention
(4)Patients under insulin therapy
glycemic control: HbA1c >=7.0%,=<9.5%
(5)Fasting plasma C-peptide >=0.5ng/mL or casual plasma C-peptide >=1.0ng/mL
(6)Having provided voluntary written consent for participation in this study.

Key exclusion criteria (1)Type 1 diabetes or secondary forms of diabetes
(2)Fasting plasma glucose <70mg/dL
(3)Renal dysfunction (eGFR <30ml/min/1.73m2)
(4)Steroid medication
(5)Hepatic dysfunction(AST and/or ALT >3X upper limit of normal)
(6)Active Malignant neoplasm
(7)Severe infection or injury
(8)Hypersensitivity to liraglutide or empagliflozin
(9)Pregnant or willing to be pregnant during this study
(10)Unable to obtain informed consent to this study
(11)Inadequacy of using this therapy

Target sample size 110

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Graduate School of Medicine,Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama Kanagawa Japan
TEL 045-787-2639
Email terauchi@yokohama-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hirotatsu Nakaguchi
Organization Graduate School of Medicine,Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama Kanagawa Japan
TEL 045-787-2639
Homepage URL
Email t156054d@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Community Health care Organization,Yokohama Central Hospital
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 横浜市立大学附属病院(神奈川県) Yokohama City University Hospital(kanagawa)
地域医療機能推進機構 横浜中央病院(神奈川県)
Japan Community Health care Organization,Yokohama Central Hospital(kanagawa)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 03 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
2017 Year 05 Month 25 Day
Anticipated trial start date
2017 Year 06 Month 02 Day
Last follow-up date
2019 Year 05 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
2017 Year 06 Month 02 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031631

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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