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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024580
Receipt No. 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

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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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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