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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026791
Receipt No. R000030754
Scientific Title A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Date of disclosure of the study information 2017/03/30
Last modified on 2019/04/02

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Basic information
Public title A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Acronym A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Scientific Title A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Scientific Title:Acronym A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Region
Japan

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

Objectives
Narrative objectives1 Ectopic adiposity including liver intracellular lipid, reducing effects and hepatic insulin resistance improving effects observed in type 2 diabetic patients using SGLT2 (empagliflozin), are compared to that of patients using DPP-4 inhibitor (sitagliptin). Also, as the characteristics of patients showing treatment efficacy, patients' background information such as insulin resistance, lipid prevalence, life style, gene expression and antidiabetic medications related to treatment efficacy are planned to elucidate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the following value changed from the baseline and the percent change:
* Amount of hepatic lipid accumulation (measured by MRI, Proton MRS)
Key secondary outcomes Evaluation of the following values changed from the baseline and the percent change:
1. Liver insulin sensitivity (measured by the hyperinsulinemic-euglycemic clamp technique)
2. Muscle, adipose insulin sensitivity (measured by the hyperinsulinemic-euglycemic clamp technique)
3. Hepatic fibrosis index (Type IV collagen 7s, ferritin, PIIIP, hyaluronic acid)
4. Liver gluconeogenesis index (cortisol)
5. Epithelial cell apoptosis index (CK18 fragment)
6. Hepatokine (hepatic hormone ) index (FGF21, Fetuin A)
7.Other index related to liver (Hepatocyte growth factor, insulin-like growth factor 1/IGF-1)
8. Adipose amount (intraperitoneal adipose amount, subcutaneous fat amount) by CT scans
9. Body weight, whole-body adipose amount, fat removal quantity, bone and muscle mass by DEXA scans
10. Physical activity level
11. Scores of the questionnaires answered by patients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Group A: Administer empagliflozin

Patients in this empagliflozin group take empagliflozin 10 mg once a day orally before or after breakfast, and continue it for 12 weeks.
Interventions/Control_2 Group B: Administer sitagliptin

Patients begin with sitagliptin 50 mg a day, in principle, and increase the dose to 100 mg from their observation point of the 4th week, if it is possible. They also take sitagliptin orally once a day before or after breakfast, and continue it for 12 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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.

1. Type 2 diabetic patients with HbA1c below 10% at the time of consenting

2. Female and male patients are 20 years old or older and younger than 75 years old

3. Patients who can take liver biopsy for the purpose of evaluation or diagnosis of non-alcohol fatty liver disease

4. Patients with BMI 22 kg/m2 or higher

5. Patients who can provide their written consent for participation of this study
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.

1. Patients with type 1 diabetes or secondary diabetes

2. Patients with BMI lower than 22 kg/m2

3. Patients with moderate to severe renal function disease or at the final stage of renal failure (eGFR lower than 45 mL/min/1.73 m2)

4. Patients who had stroke or cerebral infarction within 12 weeks before giving their consent

5. Patients with any medical history of myocardial infarction, angina pectoris, or currently with atrial fibrillation

6. Patients with any infectious disease

7. Patients with malignancy (However, those who have completed treatment and/or show no redevelopment of malignancy, as well as manifest some degree of remission can be considered to be participants of this study)

8. Patients with connective tissue disease (However, those T2DM patients who have treated with prednisolone 5 mg or less and show stable conditions can be considered to be participants of this study)

9. Patients with hepatocirrhosis

10. Patients with viral or autoimmune, or drug-induced hepatic disorder

11. Patients who are alcoholic or excessive drinkers

12. Patients who are currently pregnant, possibly pregnant, or breast-feeding during the study

13. Patients have a medical history of hypersensitivity to the study drugs

14. Patients who are in the category that the study drugs are prohibited to use

15. Patients with Hb below 12 g/dl

16. Patients with other conditions that investigators/physicians think inappropriate to be in the study
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Takahisa Hirose, Instructor Naoki Kumashiro
Organization Toho University Omori Medical Center
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 6-11-1 Omori Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email takahisa.hirose@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Department of Internal Medicine (Omori), Toho University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 30 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 03 Month 13 Day
Date of IRB
2016 Year 12 Month 15 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 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 03 Month 30 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030754

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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