UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022094 |
|---|---|
| Receipt number | R000025473 |
| Scientific Title | Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2017/12/21 09:05:10 |
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Basic information
Public title
Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study
Acronym
Comparison of Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS using CGM
Scientific Title
Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study
Scientific Title:Acronym
Comparison of Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS using 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 morning Insulin Glulisine + Insulin glargine 300 U/ml and morning Insulin lispro + Insulin glargine BS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGM
M-value(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
MAGE
MODD
mean glucose level(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
SD(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
Preprandial glucose level
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 (over 180 mg/dL) for glycemic variability within 3 h of each meal
AUC (over 0 mg/dL) for glycemic variability in 24 h
AOC (under 70 mg/dL) for glycemic variability, mg.min/dL(24:00, 8:00-12:00, 0:00-8:00)
Key secondary outcomes
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. Insulin Glulisine + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, therapy is swhiched to Insulin lispro + Insulin glargine biosimilar on day 3 and day 4.
Interventions/Control_2
CGM is attached after admission. Insulin lispro + Insulin glargine are used on day 1 and day 2. Then, therapy is swhiched to biosimilarInsulin Glulisine + Insulin glargine 300 U/ml on day 3 and day 4.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients medicated basal insulin therapy 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
30
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
Department of Diabetes
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 | 05 | Month | 02 | 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 | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025473
