UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032445
Receipt number R000037004
Scientific Title Evaluation of the effects on blood glucose level in Japanese patients with type 2 diabetes who are on diet therapy: a randomized, double-blind, crossover trial
Date of disclosure of the study information 2019/08/10
Last modified on 2022/02/14 08:15:27

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Basic information

Public title

Evaluation of the effects on blood glucose level in Japanese patients with type 2 diabetes who are on diet therapy: a randomized, double-blind, crossover trial

Acronym

Evaluation of the effects on blood glucose level

Scientific Title

Evaluation of the effects on blood glucose level in Japanese patients with type 2 diabetes who are on diet therapy: a randomized, double-blind, crossover trial

Scientific Title:Acronym

Evaluation of the effects on blood glucose level

Region

Japan


Condition

Condition

Type 2 diabetes (Adult)

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects on change of blood glucose levels with the intake of the test food

Basic objectives2

Others

Basic objectives -Others

The simultaneous studies efficacy and bio-equivalence.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood glucose level

* Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food (total 5 times).
* Assess the area under curve (AUC), the maximum blood concentration (Cmax), and the blood glucose level between before eating the test food and 120 minutes after eating the test food

Key secondary outcomes

1. Insulin
2. HOMA-beta
3. HOMA-R

*1-3 Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food (total 5 times).
* Assess the area under curve (AUC), the maximum blood concentration (Cmax), the blood insulin, HOMA-beta and HOMA-R levels between before eating the test food and 120 minutes after eating the test food. HOMA-beta and HOMA-R are calculated by the formulas:
HOMA-beta = (fasting blood insulin level x 360) / (fasting blood glucose level - 63)
HOMA-R = fasting blood insulin level x fasting blood glucose level / 405


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

6

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: single dose
Test material: Test food 1, Test food 2, and Test food 3
Administration: Eat six of each test food in 20 minutes at the examination
* Do not drink water with test food

<Intervention schedule>
[1]
Eat Test food 1
[2]
Washout period is for more than a day.
[3]
Eat Test food 2
[4]
Washout period is for more than a day.
[5]
Eat Test food 3

Interventions/Control_2

Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule>
[1]
Eat Test food 2
[2]
Washout period is for more than a day.
[3]
Eat Test food 3
[4]
Washout period is for more than a day.
[5]
Eat Test food 1

Interventions/Control_3

Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule>
[1]
Eat Test food 3
[2]
Washout period is for more than a day.
[3]
Eat Test food 1
[4]
Washout period is for more than a day.
[5]
Eat Test food 2

Interventions/Control_4

Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule>
[1]
Eat Test food 3
[2]
Washout period is for more than a day.
[3]
Eat Test food 2
[4]
Washout period is for more than a day.
[5]
Eat Test food 1

Interventions/Control_5

Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule>
[1]
Eat Test food 1
[2]
Washout period is for more than a day.
[3]
Eat Test food 3
[4]
Washout period is for more than a day.
[5]
Eat Test food 2

Interventions/Control_6

Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule>
[1]
Eat Test food 2
[2]
Washout period is for more than a day.
[3]
Eat Test food 1
[4]
Washout period is for more than a day.
[5]
Eat Test food 3

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese adult people

2. Patients with type 2 diabetes who are on diet therapy

3. Subjects who can obtain the family doctor's consent to the participation in this study if subjects have their family doctors

4. Subjects who can provide the latest blood test data and are allowed to participate in the study by the physician

5. Subjects who are judged as eligible to participate in the study by the physician

6. Within the subjects who met 5th inclusion criteria, subjects who are relatively few items of out-of-reference values in the blood test result at screening

Key exclusion criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who are anemic

3. Subjects who have dysphagia

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

5. Currently taking medicines (include herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products.

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

Naoko

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

KANRO CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com


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

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 10 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

12

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

Completed

Date of protocol fixation

2018 Year 04 Month 26 Day

Date of IRB

2018 Year 04 Month 26 Day

Anticipated trial start date

2018 Year 05 Month 07 Day

Last follow-up date

2018 Year 07 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 01 Day

Last modified on

2022 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037004


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name