UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019462 |
|---|---|
| Receipt number | R000022504 |
| Scientific Title | Investigation of factors which are related to urinary volume change after canagliflozin administration |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2016/05/19 10:51:05 |
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Basic information
Public title
Investigation of factors which are related to urinary volume change after canagliflozin administration
Acronym
Investigation of factors which are related to urinary volume change after canagliflozin administration
Scientific Title
Investigation of factors which are related to urinary volume change after canagliflozin administration
Scientific Title:Acronym
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)
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
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
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Division name
The director of clinical pharmacology center
Zip code
Address
61-1, Shinei, Kiyota-ku, Sapporo-city, Hokkaido
TEL
011-882-0111
quintilesoutcome-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tsuji |
Organization
Quintiles Transnational Japan K.K.
Division name
Medical Affairs & Clinical Science
Zip code
Address
3-4-30 Miyahara, Yodogawa-ku, Osaka
TEL
080-4880-3819
Homepage URL
quintilesoutcome-com@umin.ac.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Institute
Department
Personal name
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)
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
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 |
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
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022504
