UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026340
Receipt number 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 2022/09/05 09:06:38

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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 or person

Institute

the Japan Society for Patient Reported Outcome (PRO)

Institute

Department

Personal name



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

Main results already published

Date of protocol fixation

2016 Year 12 Month 15 Day

Date of IRB

2019 Year 10 Month 04 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2019 Year 06 Month 17 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 02 Month 28 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.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