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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026340
Receipt No. R000030257
Scientific Title A proSpective randomized Study comparing the effects of Empagliflozin versus sitagliptin on cardiac fat and function in patients with Type 2 diabetes (ASSET study)
Date of disclosure of the study information 2017/02/28
Last modified on 2018/09/26

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Basic information
Public title A proSpective randomized Study comparing the effects of Empagliflozin versus sitagliptin on cardiac fat and function in patients with Type 2 diabetes (ASSET study)
Acronym A proSpective randomized Study comparing the effects of Empagliflozin versus sitagliptin on cardiac fat and function in patients with Type 2 diabetes (ASSET study)
Scientific Title A proSpective randomized Study comparing the effects of Empagliflozin versus sitagliptin on cardiac fat and function in patients with Type 2 diabetes (ASSET study)
Scientific Title:Acronym A proSpective randomized Study comparing the effects of Empagliflozin versus sitagliptin on cardiac fat and function in patients with Type 2 diabetes (ASSET 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 To clinically evaluate the efficacy of a SGLT2 inhibitor (empagliflozin) compared to a DPP-4 inhibitor (sitagliptin) on the amount of ectopic fat accumulation with a special focus on pericardial fat, insulin resistance in tissues (heart, liver, muscle, and adipose tissues), and cardiac function among Japanese T2DM patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changed amount and percent change from baseline of the following value are evaluated:

* Amount of pericardial fat
Key secondary outcomes The changed amount and percent change from baseline of each value below are evaluated:

1. Myocardial intracellular fat amount

2. Cardiac function

3. Amount of fat accumulation in tissue (liver intracellular lipid content, intramyocellular and extramyocellular lipid contents)

4. Insulin sensitivity (in myocardium, liver, muscle, adipose tissue)

5. Myocardial fatty acid metabolism index (123I-BMIPP uptake (early/first-half image), 123I-BMIPP uptake (latter/second-half image), washout rate)

6. % suppression of EGP (suppression of hepatic glucose production rate)

7. Glucose infusion rate (GIR)

8. Glucose disappearance rate (Rd)

9. Insulin secretion index (C-peptide, plasma insulin, HOMA-beta)

10. Insulin resistance index (HOMA-IR)

11. Other insulin sensitivity index (D2Glucose, glucose level, FFA)

12. Blood glucagon

13. Energy metabolism index (calorimetric examination: amount of energy consumption, oxygen consumption and carbon dioxide emission)

14. Cardiac metabolism marker (renin activity, aldosterone, aldosterone/renin activity ratio, BNP, H-FABP)

15. Oxidation stress marker (urinary 8OHdG)

16. Inflammatory marker (hsCRP)

17. Adipose tissue hormone index (high-molecular weight adiponectin, leptin)

18. Other blood test item (quantitative albumin, HbA1c, blood glucose, TG, T-Cho, HDL, LDL, complete blood count, Na, K, Cl, uric acid, Amy, serum creatinine, eGFR, FFA, blood ketone body, AST, ALT, gamma-GTP, BUN, apolipoprotein)

19. Other urine test item (general urine test, microalbuminuria, urinary glucose, urinary ketone body, urinary Na, urinary K, urinary Cl, urinary creatinine, eGFR)

20. Body weight, blood pressure, heart rate, BMI, body composition (body fluid, bone mass, muscle mass, amount of fat, body fat percentage, basal metabolism quantity)

21. Chang in amount of meal consumed and the meal contents (BDHQ BOX)

22. Medication adherence rate (using medication adherence diary)

23. Occurrence rate of adverse events

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 the empagliflozin group take empagliflozin 10 mg once a day orally before or after breakfast 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 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. At the time of giving consent, T2DM patients whose HbA1c (NGS) is out of the range set by the Treatment Guide for Diabetes 2016-2017, which is 6.0% or higher and below 10.0% even though patients have treated with 1) a dietary and exercise regimen, or 2) monotherapy of any alpha-glucosidase inhibitor, sulphonylurea*, or glinide-based medicine in addition to a dietary and exercise regimen, or 3) a combination therapy of any alpha-glucosidase inhibitor and sulphonylurea* medicine, or any alpha-glucosidase inhibitor and glinide-based medicine in addition to a dietary and exercise regimen

2. Male and female patients who are at age of 20 years or older and younger than 75 years when giving their consent

3. Patients with BMI 22 kg/m2 or greater

4. Patients who can give their consent in a written form

*Up to glimepiride 2 mg, glibenclamide 1.25 mg, and gliclazide 40 mg are considered as sulphonylurea treatment regimen

Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study:

1. Type 1 diabetes mellitus or secondary diabetes

2. Patients with BMI below 22kg/m2

3. Moderate to severe renal function impairment or at the terminal stage of renal failure (eGFR below 45mL/min/1.73m2)

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

5. Patients with myocardial infarction or angina pectoris in the past, or with atrial fibrillation currently

6. Patient with LVEF below 30%

7. Patients with infectious disease

8. 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)

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

10. Patients with hepatocirrhosis

11. Patients with viral or autoimmune, or drug-induced hepatitis

12. Patients who are alcoholic or excessive drinkers

13. Patients are currently pregnant, possibly pregnant, breast-feeding, or planning to be pregnant during the study

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

15. If the study drugs are contradicted to use

16. Patients with Hb below 12g/dl

17. Patients with other conditions that the investigator/researcher thinks inappropriate for 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 ken.kanazawa@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 the Japan Society for Patient Reported Outcome (PRO)
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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
2017 Year 02 Month 28 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030257

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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