UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024580
Receipt number R000028290
Scientific Title Effect of concomitant use of formula diet with dapagliflozin on body compositions, metabolic improvement, and its safety in type 2 diabetes mellitus.
Date of disclosure of the study information 2017/03/01
Last modified on 2019/11/05 12:48:49

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Basic information

Public title

Effect of concomitant use of formula diet with dapagliflozin on body compositions, metabolic improvement, and its safety in type 2 diabetes mellitus.

Acronym

Effect of concomitant use of formula diet with dapagliflozin in type 2 diabetes mellitus.(Diet-Dapper study)

Scientific Title

Effect of concomitant use of formula diet with dapagliflozin on body compositions, metabolic improvement, and its safety in type 2 diabetes mellitus.

Scientific Title:Acronym

Effect of concomitant use of formula diet with dapagliflozin in type 2 diabetes mellitus.(Diet-Dapper study)

Region

Japan


Condition

Condition

Patients with type 2 diabetes mellitus who meet the following selection criteria, but not violate any of the exclusion criterion at Week 0
However, in case where an examination result about a test level of e-GFR of exclusion criteria 7) is unavailable on the prescribed day at Week 0, the most current examination result from 0 weeks to within the past 12 weeks can be adopted. In addition, in case where examination results on the prescribed day at Week 0 are obtained at a later day, and the results are found to violate the exclusion criteria, the study is to be promptly discontinue in accordance with 9.1 Discontinuation criteria.

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, inadequately controlled patients with T2DB are administered dapagliflozin and additionally supplemented with proteins by a formula diet in order to inhibit muscle loss and increase fat burning. We will inspect a hypothesis that the muscle which the patients hold/keep in this way further improves glucose metabolism through the improvement of basal metabolism and insulin-resistance. For this purpose, the treatment effect will be compared between two groups of formula diets with high proteins and with high fat.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The variation of HbA1c from starting time of the therapy to 24 weeks after starting the therapy in between two groups
Summary statistics of the change of HbA1c is calculated, and the variation from starting time of the therapy to 24 weeks after starting the therapy are compared between the two groups by the two sample t-test.

Key secondary outcomes

The variation/variation rates of the following items from starting time of the therapy to 4, 8, 12, and 24 weeks after starting the therapy in between two groups (*:at the starting time of the therapy, 12 and 24 weeks after starting the therapy,:**at 24 weeks after starting the therapy)
Summary statistics of the following items are calculated at each measurement time point, and the variation and variation rates from starting time of the therapy to 4, 8, 12, and 24 weeks after starting the therapy are compared between the two groups by the two sample t-test. In addition, an intra-group comparison is performed for the variation from starting time of the therapy to 24 weeks after starting by the one sample t-test.
The relation between variation of HbA1c and variation of other measurement contents from starting time of the therapy to 24 weeks after starting the therapy is to be evaluated by using Pearsons product moment correlation coefficient or Spearmans rank correlation coefficient.
(1) Body weight, BMI
(2) Blood pressure, heart rate
(3) Abdominal circumference
(4) Fasting blood sugar, HOMA-beta**, HOMA-R**(measurement of insulin to calculate HOMA-beta** and HOMA-R)
(5) Serum lipid level(total cholesterol, HDL-cholesterol, triglyceride, LDL-cholesterol)
(6) ketone body fraction(venous blood)**
(7) Items related to lipid:pre-heparin LPL protein**, lipoprotein fraction precision measurement**, remnant-like lipoprotein cholesterol**, apoproteins (Apo A1, A2, B, C2, C3, E)**
(8) High sensitivity CRP**
(9) Urinary albumin quantitation**
(10) ABI test/CAVI test(Only centers which can conduct these tests will measure these items.)*
(11) InBody (Only centers which can conduct this test will measure these items.)*


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

SGLT2 inhibitor (dapagliflozin) and high protein formula diet

Interventions/Control_2

SGLT2 inhibitor (dapagliflozin) and high fat formula diet

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

1) Patients whose age is <=0 years but >75 years old at the time obtaining consent
2) Patients whose HbA1c is <=7.0% but >=8.5%
3) Patients whose BMI is <=22 kg/m2
4) Patients whose eGFR is <=45 mL/min/1.73 m2 or higher
5) Patients from whom informed consent in writing is obtained voluntarily after enough understanding after having received sufficient explanation on participating of this study

Key exclusion criteria

1) Type 1 diabetic patients
2) Patients who use SGTL2 inhibitor in the past
3) Patients with hypersensitivity to the ingredient(s) of said drug
4) Patients suffering from severe ketosis, diabetic coma, or precoma
5) Patients treated with insulin
6) Patients who are judged to be inadequate to participate in this study by a doctor in charge
7) Patients with eGFR <45 ml/min/1.73 m2
8) Patients having a plan of pregnancy
9) Pregnant women, patients who might be pregnant, and lactating women
10) Patients with severe infections, patients before or after operations or having serious external injuries
11) Patients with allergy to said food ingredients (soy bean, egg, yeast,milk)

Target sample size

136


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Tatsuno

Organization

Toho University Sakura Medical Center.

Division name

Center of Diabetes, Endocrinology and Metabolism,

Zip code


Address

564-1, Shimoshizu,Sakura-City,Chiba.2858741

TEL

043-462-8811

Email

ichiro.tatsuno@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naohide Noumi

Organization

IBEC Co.,Ltd.

Division name

CEO office

Zip code


Address

Tanaka Jun Build 3F,2-5-14 Terada-cho, Tennouji-ku,Osaka-shi 5430045

TEL

06-7172-1751

Homepage URL


Email

research@ibec-jp.com


Sponsor or person

Institute

Nonprofit Organization Hokkaido Health-Science Institute

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca K.K.
ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

東邦大学医療センター佐倉病院(千葉県)
医療法人社団三咲内科クリニック(千葉県)
医療法人社団ほたるの博優会ほたるのセントラル内科(千葉県)
医療法人社団STOP DMすずき糖尿病内科クリニック(神奈川県)
医療法人社団光慈会加藤内科クリニック(東京都)
地方独立行政法人新小山市民病院(栃木県)
医療法人小山イーストクリニック(栃木県)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s13300-018-0555-5

Publication of results

Published


Result

URL related to results and publications

https://00m.in/kJDPu

Number of participants that the trial has enrolled

132

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

2016 Year 11 Month 07 Day

Date of IRB

2016 Year 11 Month 18 Day

Anticipated trial start date

2017 Year 03 Month 21 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry

2019 Year 01 Month 30 Day

Date trial data considered complete

2019 Year 02 Month 22 Day

Date analysis concluded

2019 Year 03 Month 19 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 27 Day

Last modified on

2019 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name