UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus
Title of the study (Brief title)	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	Professor Hitoshi Ishii
Organization	Nara Medical University
Division name	Department of Diabetology
Address	840 Shijo-cho,Kashihara, Nara,Japan
TEL	0744-22-3051
Email	info@japanpro.jp

Public contact
Name of contact person	Takayama Hiroki
Organization	Soiken Inc.
Division name	Patient Reported Outcome study research support center
Address	NBF 4F, 1-3-1 Kanda, Ogawamachi,Chiyoda-ku,Tokyo
TEL	03-3295-1376
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Japan society for Patient Reported Outcome
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018923