UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial-
Title of the study (Brief title)	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	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
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	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011885