UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020486 |
|---|---|
| Receipt number | R000023555 |
| Scientific Title | The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2016/06/07 10:33:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Acronym
The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Scientific Title
The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Scientific Title:Acronym
The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this crossover study, comparison of long and conventional acting basal insulin, is to evaluate the effect on day-by-day blood glucose variability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average of 2 times of mean of daily differences (MODD)
Key secondary outcomes
Day-by-day variability of fasting blood glucose
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
In the first course, insulin glargine U100 is used for 4 weeks. After the treatment of insulin glargine U100, the CGM examination is underwent. In the second course, insulin glargine U300 is used for 4 weeks. After the treatment of insulin glargine U300, the CGM examination is underwent. Insulin dose is adjusted at the beginning and 2 weeks of each course according to the titration method.
Interventions/Control_2
In the first course, insulin glargine U300 is used for 4 weeks. After the treatment of insulin glargine U300, the CGM examination is underwent. In the second course, insulin glargine U100 is used for 4 weeks. After the treatment of insulin glargine U100, the CGM examination is underwent. Insulin dose is adjusted at the beginning and 2 weeks of each course according to the titration method.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetic patient who has injected glargine U100 for more than 12 weeks.
2) HbA1c less than 9% within 4 weeks prior to entry
3) Patient who can undergo self monitoring blood glucose before each insulin injection and equip continuous glucose monitoring
Key exclusion criteria
1) severe ketosis, coma, or reduced level of con- sciousness due to diabetes within the past 6 months
2) Patients who may have been pregnant or pregnant women
3) Patients with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal)
4) Patients with moderate or severe renal dysfunction (BUN more than 25mg/dL or serum creatinine more than 2.0 mg/dL)
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Sakamoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
m-sakamoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Sakamoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
m-sakamoto@umin.ac.jp
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
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 | 01 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
