UMIN-CTR Clinical Trial

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

Type 2 diabetes (Adult)

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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 (C_max), 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 (C_max), 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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

KANRO CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2019

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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