UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016304 |
|---|---|
| Receipt number | R000018923 |
| Scientific Title | Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2017/11/24 19:25:10 |
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Basic information
Public title
Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus
Acronym
PRO study
Scientific Title
Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus
Scientific Title:Acronym
PRO study
Region
| Japan |
Condition
Condition
Overweight patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness (changes in and correlation between HbA1c, body weight, and QOL, etc.) of dapagliflozin treatment and weight-changing factors in overweight Japanese patients with type 2 diabetes mellitus who newly start using dapagliflozin in addition to their antidiabetic drug(s) prescribed before the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. QOL score change in OHA-Q
2. Correlation between changes in HbAlc and body weight and change in OHA-Q score
Key secondary outcomes
1. Changes in index values related to glycemic control: HbA1c and fasting blood glucose level
2. Changes in body weight, BMI, and abdominal circumference
3. Changes in index values related to the body composition: Fat mass, muscle mass, and bone mass
4. Changes in index values related to lipid metabolism
(TC, HDL-C, TG, LDL-C*)
*LDL-C is obtained by calculation.
6. Safety-related indices, and the incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all the following criteria are included.
1. A Japanese patient with type 2 diabetes mellitus who underwent treatment with an antidiabetic drug other than an SGLT2 inhibitor for 3 months (12 weeks) or longer in addition to diet and exercise therapies, and has not accomplished the goal in glycemic control defined in the Diabetes Treatment Guide 2014-2015 (HbA1c [NGSP] value of 7.0% or higher and less than 9.0%)
2. A patient who newly starts using dapagliflozin in addition to their antidiabetic drug(s) prescribed before the study, in line with recommendations by the Japan Diabetes Society
3. A patient with BMI >25
4. A patient with eGFR >45 ml/min
5. A male or female who is at or older than 20 years of age but younger than 60 years of age, at the time of consenting
6. A patient who has consented in writing to participate in the study
Key exclusion criteria
Patients who meet any of the following criteria are excluded from the study subjects.
1. A patient who is not using an antidiabetic drug at the time of consenting
2. A patient with a history of severe hypoglycemia within a year
3. A patient with type 1 diabetes mellitus or secondary diabetes mellitus
4. A patient with severe infection, a pre or postsurgical patient, and a patient with serious trauma
5. A patient with a history of MI (myocardial infarction), AP (angina), or CI (cerebral infarction)
6. A patient with atrial fibrillation or frequent ventricular premature contraction
7. A patient with moderate or severe heart failure (a patient at stage 3 or a higher stage of the NYHA/New York Heart Association classification)
8. A patient with moderate renal dysfunction (serum creatinine in mg/dL: male, 1.4 < female, 1.2 <)
9. A patient with severe liver dysfunction (AST 100 IU/l or higher)
10. A patient with ascites retention, and a patient with a brain disorder
11. A patient with unstable hypertension or unstable dyslipidemia within 12 weeks before consenting
12. A patient with alcohol or drug dependence
13. A patient who is pregnant or breast-feeding, suspected of being pregnant, or has a plan to get pregnant
14. A patient with dementia
15. A patient who meets a contraindication of the study drug
16. A patient who is using insulin and GLP-1, and a patient who is routinely using injectors
17.A patient conditions deemed inappropriate by an investigator in charge
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Professor Hitoshi Ishii |
Organization
Nara Medical University
Division name
Department of Diabetology
Zip code
Address
840 Shijo-cho,Kashihara, Nara,Japan
TEL
0744-22-3051
info@japanpro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayama Hiroki |
Organization
Soiken Inc.
Division name
Patient Reported Outcome study research support center
Zip code
Address
NBF 4F, 1-3-1 Kanda, Ogawamachi,Chiyoda-ku,Tokyo
TEL
03-3295-1376
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan society for Patient Reported Outcome
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K. and ONO PHARMACEUTICAL CO.
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
This study is conducted at approximately 30 collaborating research institutions in Japan where full-time diabetes specialists and investigators with adequate experience in the treatment of diabetes mellitus are available. Juntendo University,Shizuoka Saiseikai General Hospital and Takagi Hospital etc.
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 11 | Day |
Other
Other related information
The QOL score is measured using OHA-Q at week 0 (baseline) and the week 14 observation point in overweight Japanese patients with type 2 diabetes mellitus who newly start using dapagliflozin in addition to their antidiabetic drug(s) prescribed before the study. In addition, blood markers, body weight, changes in the body composition are observed.
Management information
Registered date
| 2015 | Year | 01 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018923
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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