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
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
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
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
