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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020239
Receipt No. 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 2019/04/30

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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
Email 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
Email hqchiken@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 No longer recruiting
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
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.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


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