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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010634
Receipt No. R000012435
Scientific Title Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Date of disclosure of the study information 2013/05/01
Last modified on 2015/03/31

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Basic information
Public title Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Acronym Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Scientific Title Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Scientific Title:Acronym Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Region
Japan

Condition
Condition Type 1 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy (changes in insulin dose and glycosylated hemoglobin) and safety (frequency of hypoglycemic events) of degludec by switching from other long-acting insulin (once daily or twice daily) in patients with type 1 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in HbA1c at 4, 12 and 24 weeks and insulin dose
Key secondary outcomes Changes in mean blood glucose level, SD value, MAGE value, rate and duration of hyper/hypoglycemia, glycemic pattern and area under the carve after long-acting insulin injection, (evaluated by SMBG/CGM), body weight, and frequency of hypoglycemia

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In patients those who are injecting long-acting insulin (1) once daily or (2) twice daily, long-acting insulin are switched to insulin degludec once daily injection. Initial degludec doses are transferred 1:1 from pretreated insulin (in group (2), the sum of two doses), or 80% for the cases with a risk of hypoglycemia. Insulin doses are then changed according to the protocol "KITANO Tresiba protocol".
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 type 1 diabetes who are on insulin basal-bolus therapy
2. Age: >20 years-old
Key exclusion criteria 1. The patients who did not agree with this study
2. The patients with serious complications
3. The patients who are at high risk for hypoglycemia
4. The patients who have the history of severe hypoglycemia (needed an emergency transport according to the hypoglycemia unawareness)
5. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Hamamoto
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Center for Diabetes and Endocrinology
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Center for Diabetes and Endocrinology
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL 06-6312-1221
Homepage URL
Email

Sponsor
Institute Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute
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 05 Month 01 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 Completed
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 01 Day
Last modified on
2015 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012435

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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