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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012458
Receipt No. R000014581
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)
Date of disclosure of the study information 2013/12/02
Last modified on 2013/12/02

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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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