UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Title of the study (Brief title)	Effect of canagliflozin on microalbuminuria in type 2 diabetic patients
Region	Japan

Condition
Condition	Type 2 diabetic patients with microalbuminuria
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of canagliflozin on diabetic nephropathy in type 2 diabetic patients with microalbuminuria by evaluating 24-hr urine albumin excretion. In addition, several markers of renal impairment are exploratory studied.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Percent change in the 24-hour urine albumin excretion level (mg/day) from baseline to 12 weeks.
Key secondary outcomes	Changes or percent changes in the following markers from baseline to 12 weeks. 1) HbA1c, fasting blood glucose 2) Body weight, BMI 3) eGFR (by serum creatinine, serum cystatin C), creatinine clearance 4) Urinary albumin (first morning voids, creatinine ratio) 5) Tubular and glomerular damage marker: Urinary type IV collagen, urinary transferrin, urinary NAG, urinary L-FABP, urinary B2 microglobulin, urinary NGAL, urinary KIM-1, serum TNFR1, serum TNFR2 6) Inflammatory marker: Serum IL-18, Serum high-sensitivity C-reactive protein 7) Oxidative stress marker: Urinary 8-OHdG 8) Blood pressure, serum uric acid, urinary aldosterone, serum aldosterone, plasma renin activity 9) Hematocrit 10) Serum erythropoietin 11) Absolute change in the 24-hour urine albumin (mg/day)

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, once daily, before or after breakfast, oral administration
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	1. Type 2 diabetes 2. Age >=20, 75> years on the date of submission of informed consent 3. Submission of written informed consent for participation in the study The following criteria are confirmed by data available on the visit for eligibility confirmation. 4. HbA1c=<10%(NGSP) In case of patients with age >=65, 75> years administered with SU and/or glinide, 6.5%=<HbA1c=<10%(NGSP) 5. Blood pressure: <140/90mmHg 6. Urinary albumin: 30.0-299.9mg/g.Cr (first morning voids) 7. eGFR>=45mL/min/1.73m2
Key exclusion criteria	1. Type 1 diabetes 2. The following drugs are administered (the date of submission of informed consent)SGLT2 inhibitor Insulin GLP-1receptor agonist 3. History of hypersensitivity to canagliflozin 4. Has severe ketosis, diabetic coma or semi-coma 5. Has severe infection, trauma or perioperative 6. Possible or definitive pregnant women or nursing mother 7. Has malignant tumor or suspicious for 8. Has urinary tract infection 9. Has NYHA class IV heart failure 10. Has severe anemia 11. Considered not eligible for the study by principal or other investigators due to other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Osonoi
Organization	Nakakinen clinic Medical Corporation Kensei-kai
Division name	Director
Address	745-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Email	k-ofuchi@kensei-kai.com

Public contact
Name of contact person	Kensuke Ofuchi
Organization	Nakakinen clinic Medical Corporation Kensei-kai
Division name	department of clinical research
Address	745-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Nakakinen clinic Medical Corporation Kensei-kai
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2017 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027582