UMIN-CTR Clinical Trial

Basic information
Public title	Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients)
Acronym	Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec (Study on inpatients)
Scientific Title	Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients)
Scientific Title:Acronym	Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec (Study on inpatients)
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of switching from existing long-acting insulin to insulin degludec for inpatients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of HbA1c levels after 12 weeks from baseline, achievement rate of HbA1c <7.0% and frequency of hypoglycemia in observation period
Key secondary outcomes	1)Percentage of time periods at which blood glucose level is 70mg/dL or lower during using CGM 2)Percentage of time periods at which blood glucose level is 180mg/dL or more during using CGM 3)Average blood glucose level, standard deviation (SD) of blood glucose and coefficient of variation (CV) during wearing CGM 4)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 5)SD of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 6)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 7)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 8)Change of insulin dosage 9)Changes of DTSQs, DTSQc 10)Changes of weight, BMI

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	Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have received insulin therapy including once-daily-administration of long-acting insulin for more than 12 weeks in addition to diet therapy and exercise therapy, and also fits the following requirement 1)HbA1c<=7.0% 2)Age between 20-80, regardless of sex
Key exclusion criteria	1)Patients who take long-acting insulin twice daily 2)Patients in contraindication of degludec 3)Patients who were considered not to be appropriate for administration of degludec by their doctors. 4)Patients who take high dosage of sulfonylurea drug: 3mg or more Glimepiride a day, 5mg or more Glibenclamide a day, 80mg or more Gliclazide a day. 5)Patients who take GLP-1 receptor agonist in combination
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masato Odawara
Organization	Tokyo Medical University
Division name	The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)
Zip code
Address	Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	naika3@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Junpei Shikuma
Organization	Tokyo Medical University
Division name	The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)
Zip code
Address	Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	naika3@tokyo-med.ac.jp

Sponsor
Institute	The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University
Institute
Department

Funding Source
Organization	The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo 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
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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 02 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	Preinitiation
Date of protocol fixation	2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 02 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 12 Month 02 Day
Last modified on	2013 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014581

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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