UMIN-CTR Clinical Trial

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
Institute	Nonprofit Organization Hokkaido Health-Science Institute
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028290