UMIN-CTR Clinical Trial

Public title

Food in Eu(iso)-Energic Diet in
Nutritional Glucose Manipulate urinary
Elimination

Acronym

FEEDING-ME

Scientific Title

Food in Eu(iso)-Energic Diet in
Nutritional Glucose Manipulate urinary
Elimination

Scientific Title:Acronym

FEEDING-ME

Region

Japan

Condition

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For type 2 diabetes patients with severe hyperglycemia,the sodium glucose
transporter 2 inhibitor or eliminated
carbohydrate diet which is equal to
urinary glucose caused by SGLT2 inhibitor will be added to insulin intensive
therapy.
It is intended to be compared movement of consumptive energy before and after meal, also,effects of reduction of blood
glucose between two groups.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

respiratory quotient and energy
consumption of meal tolerance test by
indirect calorimetry
(pre research period,post 7days,
12weeks at the research period)

Key secondary outcomes

1. total insulin use and period until
normal blood glucose response
(fasting blood glucose less than 110mg/dl,average plasma glucose less than 126mg/dl)
2. index of blood glucose control:
change of casual blood glucose by self
monitoring blood glucose during research
period
3. index of blood ketone body:casual
beta-Hydroxybutyric acid measured by
beta-ketone body measuring-instrument and
total ketone body measured by clinical
test during research period
4. changes of body weight,blood pressure,
and body mass index during research period
5. change of urine volume,urination
frequency, urinary glucose per day
during research period
6. an index of lipid parameters(total
cholesterol,triglyceride,HDL cholesterol,
LDL cholesterol)(pre research period,
post 7days,4weeks,8weeks,12weeks at the
research period)
7. pancreas beta cell function:plasma CPR etc.(pre research period,post 7days,
12weeks at the research period)
8. degree of satisfaction of treatment:
questionnaire with Diabetes
Therapy-Related QOL (DTR-QOL)
(pre research period,post 12weeks at the
research period)
9.neurological evaluation of energy
metabolism of meal tolerance test
(pre research period,post 12weeks at the
research period)
10. evaluation of safety:Symptoms of
hypoglycemia or hyperglycemia,digestive
or other harmful phenomenon,abnormal
data of clinical exam during research
period
11.change of plasma marker of energy
metabolism, various carbonic acid
concentration and body composition
(pre research period,post 7days,
12weeks at the research period)
12.evaluation of compliance of
nutritional intake by BDHQ
(pre research period,post 4weeks,12 weeks at the research period)
13.evaluate changes of blood glucose,the
marker of carbohydrate and lipid
metabolism,during meal tolerance test.
(pre research period,post 7days,12 weeks
at the research period)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Food

Interventions/Control_1

Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(28kcal/kg)

Interventions/Control_2

Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(28kcal/kg)
Drug therapy Canagliflozin (100mg/day)

Interventions/Control_3

Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(25kcal/kg,carbo ratio 60%
and about -50g/day)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

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. Insulin independent Type 2 diabetes
patients controlled inadequately with
HbA1c more than 8.0%
2. Patients who does not use human GLP-1
analog or insulin or SGLT2 inhibitor
3. Patients who can understand consent
brief and other explanation documents
having the ability of the agreement about participation in this examination

Key exclusion criteria

1.Type 1 diabetes mellitus patients or
secondary diabetic mellitus
2.Patients who had myocardial infarction
within 3 months,or obvious heart failure
case
3.Patients who had the past
hypersensitivity for the used drug
4.Patients with diabetic ketoacidosis or
diabetic coma or risk of diabetic coma
5.Patients with severe liver disease
6.Patients with severe renal disease
7.Patients with severe pancreas disease
8.Patients during cancer treatment
9.Patients with hemoglobin (Hb) less than 11g/dL
10.Patients that the number of the
platelets is less than 100,000 /mm3
11.Patients with severe diabetic
neuropathy
12.Patients having a proliferative
retinopathy
13.Patients with a serious infectious
disease or during a surgery period or
a serious injury
14.Excessive common custom drinker
15.A pregnant woman or the woman who may
be pregnant
16.In addition, the patients who will be
judged inappropriate by an attendant
physician

Target sample size

39

Name of lead principal investigator

1st name
Middle name
Last name	Hirose Takahisa

Organization

Toho University School of Medicine

Division name

Division of diabetes,metabolism and endocrinology

Zip code

Address

6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan

TEL

03-3762-4151(6560.6565)

Email

takahisa.hirose@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroyuki Igarashi

Organization

Toho University School of Medicine

Division name

Division of diabetes,metabolism and endocrinology

Zip code

Address

6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan

TEL

03-3762-4151(6560.6565)

Homepage URL

Email

hiroyuki.igarashi@med.toho-u.ac.jp

Institute

Toho University School of Medicine
Division of diabetes,metabolism and
endocrinology

Institute

Department

Personal name

Organization

Mitubishi Tanabe Pharma Corporation
Ikuyaku Integrated Value Development
division of research and Ikuyaku

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東邦大学医療センター大森病院（東京都）

Date of disclosure of the study information

2017

Year

05

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

12

Day

Date of IRB

2016

Year

11

Month

17

Day

Anticipated trial start date

2017

Year

05

Month

09

Day

Last follow-up date

2019

Year

01

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

07

Day

Last modified on

2019

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031165