UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012198 |
|---|---|
| Receipt number | R000014264 |
| Scientific Title | The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2014/05/27 17:06:37 |
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Basic information
Public title
The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Acronym
The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Scientific Title
The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Scientific Title:Acronym
The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of insulin Decludec on glucose fluctuation with the effects of insulin Glargine by using CGMS(Continuous Glucose Monitoring System)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily Glucose fluctuation (MAGE, SD), incidence of hypoglycemia, change of QOL
Key secondary outcomes
fasting glucose level, daily insulin dose
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin Glargine is replaced to insulin Degludec. CGM is performed before and immediately after replacement for 6 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)HbA1c values 6.5%-12%
2)Patients medicated with insulin Glargine for more than 3 month
Key exclusion criteria
1)Patients with hypersensitivity to Degludec
2)Patients with severe renal or liver failure
3)Patients with proliferative diabetic retinopathy (except for stable condition by photocoagulation)
4)Patients who are pregnant or in lactation period
5)Patients who achieve good plasma glucose levels by treatment with insulin Glargine
6)Judged as ineligible by clinical investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Nakamura |
Organization
Aichi Medical University
Division name
Division of Diabetes, Department of Internal Medicine, Diabetes Center
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-63-1683
jiro@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kato |
Organization
Aichi Medical University
Division name
Division of Diabetes, Department of Internal Medicine, Diabetes Center
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-63-1683
Homepage URL
ykato4@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Department of Internal Medicine, Diabetes Center,Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Department of Internal Medicine, Diabetes Center,Aichi Medical University
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 | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | 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 | 11 | Month | 01 | Day |
Last modified on
| 2014 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014264
