UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010847 |
|---|---|
| Receipt number | R000012700 |
| Scientific Title | Comparison of Insulin degludec vs. Insulin glargine using continuous glucose monitoring (CGM): Crossover study |
| Date of disclosure of the study information | 2013/05/31 |
| Last modified on | 2013/11/30 13:31:25 |
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Basic information
Public title
Comparison of Insulin degludec vs.
Insulin glargine using continuous glucose
monitoring (CGM): Crossover study
Acronym
Degludec vs. Glargine using CGM: Crossover study
Scientific Title
Comparison of Insulin degludec vs.
Insulin glargine using continuous glucose
monitoring (CGM): Crossover study
Scientific Title:Acronym
Degludec vs. Glargine using CGM: Crossover study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of Insulin degludec
vs. Insulin glargine using CGM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
M-value, MAGE, mean glucose level etc.
Key secondary outcomes
U-CPR, BNP, PAI-1 etc.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
During Stage I, the D/G group received insulin degludec. After 1 month of treatment, patients were hospitalized for 4 days, and blood glucose levels were measured for two consecutive days using CGM. During Stage II, the D/G group received insulin glargine. Basal insulin dose of Stage II were the same of that of Stage I. After 1 month of Stage II treatment, subjects were hospitalized for another 4 days to measure blood glucose levels for two consecutive days.
Interventions/Control_2
During Stage I, the G/D group received insulin glargine. After 1 month of treatment, patients were hospitalized for 4 days, and blood glucose levels were measured for two consecutive days using CGM. During Stage II, the G/D group received insulin degludec. Basal insulin dose of Stage II were the same of that of Stage I. After 1 month of Stage II treatment, subjects were hospitalized for another 4 days to measure blood glucose levels for two consecutive days.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients medicated insulin therapy for 3 month or longer
Key exclusion criteria
1) severe renal dysfunction (serum creatinine level ≥2 mg/dL)
2) judged to be unsuitable for participation for medical reasons.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1-Kaimei hira-Ichinomiya city-Aichi
TEL
0586-48-0077
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1-Kaimei hira-Ichinomiya city
TEL
0586-48-0077
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2013 | Year | 05 | Month | 31 | 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
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 31 | 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
| 2013 | Year | 05 | Month | 31 | Day |
Last modified on
| 2013 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012700
