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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010148
Receipt No. 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

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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
Email 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
Email hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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