UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010148 |
|---|---|
| Receipt number | R000011885 |
| Scientific Title | Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial- |
| Date of disclosure of the study information | 2013/03/07 |
| Last modified on | 2018/04/03 21:40:00 |
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Basic information
Public title
Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial-
Acronym
Change in variability of glucose daily profile by switching Glargine to Degludec
Scientific Title
Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial-
Scientific Title:Acronym
Change in variability of glucose daily profile by switching Glargine to Degludec
Region
| Japan |
Condition
Condition
type1 or type2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare variability of glucose daily profile using Continuous Glucose Monitoring System between insulin Glargine and insulin Degludec in patients with diabetes during intensive insulin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Variability of glucose daily profile (MAGE) using Continuous Glucose Monitoring System
Key secondary outcomes
1) hypo- and hyper- glycemic area of glucose daily profile using Continuous Glucose Monitoring System (AUCglucose24h, AUCglucose0-6am, AUCglucose24h of less than70mg/dl, AUCglucose0-6am of less than 70mg/dl), 2) change of insulin dose, 3) Frequency of hypoglycemia (awareness and unawareness), 4) levels of insulin antibody
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) patients with diabetes (type1 or type2) under treatment by intensive insulin therapy including insulin Glargine whose glycemic control range is less than 130mg/dl mean in fasting blood glucose level and, less than 180mg/dl in mean postprandial blood glucose level, 2) written informed consent
Key exclusion criteria
1) patients with unstable diabetic retinopathy, 2) severe hepatic dysfunction, renal dysfunction, heart failure, 3) history of anaphylaxis of insulin Degludec or insulin Glargine, 4) pregnancy, 5) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）、NTT東日本病院（北海道）、KKR札幌病院（北海道）、市立札幌病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
To compare variability of glucose daily profile using Continuous Glucose Monitoring System between insulin Glargine and insulin Degludec in patients with diabetes during intensive insulin therapy
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011885
