UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020239 |
|---|---|
| Receipt number | R000023371 |
| Scientific Title | Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. SUMS-ADDIT-2 |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2022/07/12 09:23:18 |
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Basic information
Public title
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus.
SUMS-ADDIT-2
Acronym
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus.
SUMS-ADDIT-2
(Shiga University of Medical Science Anti-Diabetic Drugs Intervention Study-2)
Scientific Title
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus.
SUMS-ADDIT-2
Scientific Title:Acronym
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus.
SUMS-ADDIT-2
(Shiga University of Medical Science Anti-Diabetic Drugs Intervention Study-2)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of dapagliflozin on changes in body weight from 0 to 24 weeks of Japanese patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body weight from 0 to 24 weeks
Key secondary outcomes
Changes and percent changes of following parameters from 0 to 24 weeks
1) Physical findings
- Systolic/diastolic blood pressure
- Pulse
2) Body composition
- Fat mass, lean body mass, and bone density measured by DEXA
- Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level, iliopsoas muscle area, and volume of the liver measured by MRI
- Intrahepatic fat mass and hepatic glycogen content measured by MRS
- Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level measured by Dual Scan
- Fat mass and muscle mass (right and left arms, right and left lower limbs, and body trunk) and water volume measured by weight scale and body composition scale
3) Glucose metabolism
HbA1c, Fasting plasma glucose, 1,5-AG, Fasting CPR, Fasting plasma insulin, Fasting urinary glucose, Glucagon
4) Lipid metabolism
Total cholesterol, LDL cholesterol, HDL cholesterol, Triacylglycerol, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid, Free glycerol, RLP cholesterol
5) Liver function tests
ALT, AST, Gamma-GTP, ChE, Ferritin
6) Others
Urinary albumin, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), lipid metabolites majored by lipidomics, mRNA expression in PBMC, Erythropoietin, Food preference questionary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 5 mg dapagliflozin once a day after breakfast
Interventions/Control_2
Antidiabetic agent except for insulin and GLP-1 agonist
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) Aged >= 20, <75 at consent
2) Type 2 diabetes patients undergoing oral antidiabetic agent therapy
3) HbA1c > 7.0% and < 10.0%
4) BMI > 23 kg/m2
5) eGFR > 45 ml/min/1.73m2
6) Outpatient
7) Provided written informed consent
Key exclusion criteria
1) History of receiving a SGLT-2 inhibitor
2) Receiving insulin or GLP-1 agonist
3) With severe ketosis, diabetic coma, or precoma
4) Contraindication to the use of dapagliflozin (history of hypersensitivity to dapagliflozin, or pregnant, etc.)
5) History of hospitalization for infection, trauma, or surgery within 6 months
6) History or under treatment of brain infarction, transient ischemic attack
7) With an episode of angina pectoris or myocardial infarction within 6 months
8) Receiving loop diuretics
9) With orthostatic hypotension
10) Considered inadequate by the investigator
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Katsutaro |
| Middle name | |
| Last name | Morino |
Organization
Shiga University of Medical Science
Division name
Department of Diabetes, Nephrology and Neurology
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-2222
morino@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Kawanishi |
Organization
Shiga University of Medical Science
Division name
Clinical Reseach and Development Center
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-3619
Homepage URL
hqchiken@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
ONO PHARMACEUTICAL CO., LTD.
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051180018
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
滋賀医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0168822722005939?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0168822722005939?via%3Dihub
Number of participants that the trial has enrolled
52
Results
The change in BM was significantly larger in the Dapa than in the Con group, with a difference in the mean change of-1.72 kg (95 %CI: -2.85, -0.59; P = 0.004) between the groups. IHTG content was significantly reduced in the Dapa than in the Con (P = 0.033). Changes in AAs showed small differences between the groups, but only serine concentrations were significantly reduced in the Dapa.
Results date posted
| 2022 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were outpatients with type 2 diabetes aged 20-75 years who had glycated hemoglobin (HbA1c) values of 7.0%-10.0% and a BM index over 23 kg/m2. At the time of enrollment, they were all being treated with oral anti-diabetic agents other than SGLT2 inhibitors and had estimated glomerular filtration rates over 45 mL/min/1.73 m2.
Participant flow
Eighty-one eligible patients with type 2 diabetes mellitus were screened at Shiga University of Medical Science Hospital between February 2016 and June 2017, and 52 were enrolled in the present study. The participants were randomly assigned to the Dapa group (n = 26) or the control group (n = 26).
Adverse events
Hypoglycemia, dehydration, urinary tract infection, and exanthema occurred in both groups.
Outcome measures
The primary outcome was the change in total BM (TBM) between baseline and 24 weeks. The secondary outcomes were as follows:
changes in body fat mass and fat-free mass changes in bone mineral density as measured using dual energy X-ray absorptiometry (DEXA); changes in subcutaneous fat mass at the umbilicus, visceral fat mass at the umbilicus, liver volume, and iliopsoas surface area as measured by magnetic resonance imaging (MRI); changes in IHTG content as measured by 1H-magnetic resonance spectroscopy (MRS); and changes in fat mass and lean body mass as measured by bioelectrical impedance analysis (BIA). We measured 36 plasma amino acids.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023371
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/07/08 | Form.sas |
