UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023972 |
|---|---|
| Receipt number | R000027595 |
| Scientific Title | Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM): randomised crossover study |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2017/03/09 14:33:56 |
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Basic information
Public title
Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM): randomised crossover study
Acronym
Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM)
Scientific Title
Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM): randomised crossover study
Scientific Title:Acronym
Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM)
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect between Insulin glargine 300 U/ml + Tofogliflozin 20 mg + Insulin glargine 300 U/ml + Ipragliflozin 50 mg
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGM
AOC (70 mg/dL) for glycemic variability (0:00-6:00, 24:00)
day2 day14
Key secondary outcomes
M-value (0:00-6:00, 24:00, 8:00-24:00)
MAGE
MODD
ADRR
mean glucose level (0:00-6:00, 24:00, 8:00-24:00)
SD (0:00-6:00, 24:00, 8:00-24:00)
Highest postprandial glucose level within 3 hours after each meal
Time from start of meal to the highest postprandial glucose level
Differences between preprandial and highest postprandial glucose level for each meal
post-breakfast glucose gradient
AUC (140 mg/dL) for glycemic variability within 3 h of each meal
AUC (0 mg/dL) for glycemic variability in 24 h
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CGM is attached after admission. Tofogliflozin 20 mg + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, Ipragliflozin 50 mg + Insulin glargine 300 U/ml are used on day 13 and day 14.
Interventions/Control_2
CGM is attached after admission. Ipragliflozin 50 mg + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, Tofogliflozin 20 mg + Insulin glargine 300 U/ml are used on day 13 and day 14.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients medicated Insulin glargine 300 U/ml for 3 month or longer
Key exclusion criteria
severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
judged to be unsuitable for participation for medical reasons
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeishi Soichi |
Organization
General Inuyamachuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeishi Soichi |
Organization
General Inuyamachuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL
0568-62-8111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
General Inuyamachuo Hospital
Institute
Department
Personal name
Funding Source
Organization
General Inuyamachuo Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 07 | 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
| 2016 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 07 | Day |
Last modified on
| 2017 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027595
