UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of factors which are related to urinary volume change after canagliflozin administration
Title of the study (Brief title)	Investigation of factors which are related to urinary volume change after canagliflozin administration
Region	Japan

Condition
Condition	Type2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of factors which are related to transient urinary volume change after canagliflozin administration, by evaluating endogenous hormones that are related to urinary volume change, in Japanese patients with type2 diabetes mellitus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Urinary volume, the change of urinary volume, correlation between those parameters and factors which are related to urinary volume change
Key secondary outcomes	Blood glucose, the change of GLP-1 concentration, safety(adverse event, general clinical examination, electrocardiogram)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Canagliflozin 100mg, administration of once a day, for 6 days
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Age >= 25 years and < 75 years 2. Male and Female 3. Patients whose symptoms of type2 diabetes are stable. 4. If patients treated with one or two oral hypoglycemic agents, dose of them are stable over 3months. 5. BMI >=20kg/m2 and <=35kg/m2 6. HbA1c >= 7.0% and <= 10.0% 7. SBP >= 95mmHg and<= 160 mmHg, DBP >= 50 mmHg and <=100mmHg 8. Estimated glomerular filtration rate (eGFR)>=60 ml/min/1.73m2 9. Consent to study participation has been obtained in writing from the patient personally
Key exclusion criteria	1. Patients who have not received treatment of type 2 diabetes mellitus(diet therapy, exercise therapy, oral hypoglycemic agent and so on) 2. Patient with type 1 diabetes mellitus or with history of secondary diabetes mellitus 3. Patients who have experienced repeated severe hypoglycemic episodes 4. Patients with the history of serious diabetic complications requiring treatment 5. Patients treated with insulin, GLP-1 receptor agonist, SGLT-2 inhibitor, diuretic (including drug combination) 6. Patients with history of , or concurrent complication that affect renal function(renal disease, renal stone, prostatic inflammation and so on) , or patients with urinary-tract infection 7. Patients with history of drug or food allergies 8. Patients with history of myocardial infarction, congestive heart failure, unstable angina, cerebrovascular disease(except for lacunar infarction)within 6 months prior to screening visit (confirmation of eligibility) 9. Patients with history of TIA or cerebral infarction with clear neurological symptoms 10. Patients with peripheral arterial disease; Fontaine grade 3 or 4 11. Patients who correspond to contraindication or careful administration of canagliflozin (except for patient under treatment of hypoglycemic agents) 12. Patients with history of atrial fibrillation 13. Patients who are judged as inappropriate by investigators on screening examination.
Target sample size	12

Research contact person
Name of lead principal investigator	Kazuhiko Takano
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Division name	The director of clinical pharmacology center
Address	61-1, Shinei, Kiyota-ku, Sapporo-city, Hokkaido
TEL	011-882-0111
Email	quintilesoutcome-com@umin.ac.jp

Public contact
Name of contact person	Tetsuya Tsuji
Organization	Quintiles Transnational Japan K.K.
Division name	Medical Affairs & Clinical Science
Address	3-4-30 Miyahara, Yodogawa-ku, Osaka
TEL	080-4880-3819
Homepage URL
Email	quintilesoutcome-com@umin.ac.jp

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Mitsubishi Tanabe Pharma Cooperation
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	医療法人北武会 美しが丘病院（北海道） Medical Corporation Hokubukai Utsukushigaoka Hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 11 Day
Anticipated trial start date	2015 Year 10 Month 28 Day
Last follow-up date	2015 Year 12 Month 15 Day
Date of closure to data entry	2016 Year 01 Month 08 Day
Date trial data considered complete	2016 Year 01 Month 15 Day
Date analysis concluded	2016 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2016 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022504