UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the efficacy of dapagliflozin in patients with type 2 diabetes
Acronym	Efficacy of dapagliflozin
Scientific Title	Examination of the efficacy of dapagliflozin in patients with type 2 diabetes
Scientific Title:Acronym	Efficacy of dapagliflozin
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We add dapagliflozin and evaluate blood glucose improvement effect.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Fasting plasma glucose and HbA1c after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible.
Key secondary outcomes	Change of body weight, blood pressure, kidney and liver function, lipid profile, and blood dapagliflozin concentrations after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible. Blood dapagliflozin concentrations is measured until 36 months. Adverse event. Kidney function is urinary albumin, L-FABP and eGFR etc.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We give dapagliflozin 5mg/day after an agreement for 36 months, extend if possible. Evaluate;before and 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible Observation period;From May1,2016 to reach planned number of cases
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes BMI 23kg/m2<= eGFR30ml/min/1.73m2<=
Key exclusion criteria	1.Patients with hypersensitivity to an ingredient of dapagliflozin 2.Diabetic ketoacidosis 3.Past history of coma or severe hypoglycemia 4.Severe infection or serious trauma 5.Severe liver injury, renal failure, cardiac disease, proliferative retinopathy 6.Past history of cerebral infarction 7.Past history of malignant tumor 8.Women with during pregnancy, nursing, or pregnant likelihood 9.Inadequate patients judged by doctor
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Hayakawa
Organization	Tonami general hospital
Division name	Department of diabetes mellitus and endocrinology
Zip code	939-1395
Address	1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL	0763-32-3320
Email	thayakawa-endo@umin.ac.jp

Public contact
Name of contact person	1st name Tetsuo Middle name Last name Hayakawa
Organization	Tonami general hospital
Division name	Department of diabetes mellitus and endocrinology
Zip code	939-1395
Address	1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL	0763-32-3320
Homepage URL
Email	thayakawa-endo@umin.ac.jp

Sponsor
Institute	Tonami general hospital Department of diabetes mellitus and endocrinology
Institute
Department

Funding Source
Organization	Tonami general hospital Department of diabetes mellitus and endocrinology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	Department of pharmacokinetics, Kyoto pharmaceutical university
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tonami general hospital
Address	1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
Tel	0763-32-3320
Email	thayakawa-endo@umin.ac.jp

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	市立砺波総合病院（富山県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 01 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	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 23 Day
Date of IRB	2016 Year 02 Month 23 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 17 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025314