UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016347 |
|---|---|
| Receipt number | R000018659 |
| Scientific Title | Study for the effect of blood glucose and metabolic risk factors by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes. -prospective observational study- |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2018/06/05 10:45:38 |
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Basic information
Public title
Study for the effect of blood glucose and metabolic risk factors
by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes.
-prospective observational study-
Acronym
Switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes
Scientific Title
Study for the effect of blood glucose and metabolic risk factors
by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes.
-prospective observational study-
Scientific Title:Acronym
Switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the effectiveness of
Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Frequency of hypoglycemia and glycemic control
Key secondary outcomes
Weight, BMI, Waist, Lipid metabolism, Blood pressure,Liver function, Complete blood count, renal function, electrolyte
Dose and period of Sulfonylurea before clinical trial, Dose change of Sulfonylurea, Change of insulin dose
(only patients using insulin)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with type 2 diabetes who have been taking Sulfonylurea, Glimepride(>=1 mg),Gliclazide (>=40 mg), Glibenclamide (>=1.25 mg) for more than 12 weeks, and are starting Ipragliflozine.
2)20 to 75 years old
3)BMI>=22 kg/m2
4)eGFR>=45 ml/min/1.73 m2
5)HbA1c 6.5 to 8.5 %
6)Written informed consent
Key exclusion criteria
1)Hypersensitivity to Ipragliflozine
2)Uncontrolled diabetic retinopathy
3)Severe liver dysfunction,renal dysfunction,or heart failure
4)Pregnancy,nursing woman or possibly pregnant woman
5)Severe diabetic ketosis,diabetic coma
6)Severe infection,pre and post operation,severe trauma
7)Deficiency of insulin secretion (fasting CPR <0.5 ng/ml)
8) Patients who are inadequate to enter this study due to uncontrolled diet therapy or the other reasons by physician's judgments
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
北海道大学病院（北海道）、小笠原クリニック札幌病院付属外来プラザ（北海道）、沖病院（北海道）、帯広厚生病院（北海道）、釧路赤十字病院（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、栗原内科（北海道）、高橋清仁クリニック（北海道）、苫小牧市立病院（北海道）、にわ糖尿病・内科クリニック（北海道）、北海道中央労災病院せき損センター（北海道）、萬田記念病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
| 2014 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assess the effectiveness of
Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018659
