UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011550 |
|---|---|
| Receipt number | R000013461 |
| Scientific Title | Efficacy and safety of insulin degludec in Japanese type 2 diabetes |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/08/22 13:50:24 |
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Basic information
Public title
Efficacy and safety of insulin degludec in Japanese type 2 diabetes
Acronym
Efficacy and safety of insulin degludec in Japanese type 2 diabetes
Scientific Title
Efficacy and safety of insulin degludec in Japanese type 2 diabetes
Scientific Title:Acronym
Efficacy and safety of insulin degludec in Japanese type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaludate effects ob glargine-to-degludec switch on glycemic control and hypoglycemia in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose variability by Continuous Glucose Monitoring System
Key secondary outcomes
Frequency of hypoglycemia,
Blood glucose plofile measured by SMBG,
HbA1c,
1,5-AG,
insulin dose
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
Insulin glargine is replaced to insulin degludec with same dose. The dose of insulin degludec is adjusted every 2 weeks. CGM is performed before and 6 weeks after replacement.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with type 2 diabetes,who are on insulin glargine therapy
(2)HbA1c >7.0%
(3)written informed consent
Key exclusion criteria
(1)severe ketosis, diabetic coma
(2)history of severe hypoglycemia
(3)severe renal dysfunction (eGFR <30) and hepatic dysfunction
(4)pancreatic deasease, endocrine deasease, taking diabetogenic medication
(5)pregnancy
(6)unable to self-injection
(7)allergy for degludec or glargine
(8)judged as ineligible by clinical investigators for some other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Kuramoto |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Metabolism and Endocrinology
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
naoki.kuramoto@c5.kepco.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Kuramoto |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Metabolism and Endocrinology
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
Homepage URL
naoki.kuramoto@c5.kepco.co.jp
Sponsor or person
Institute
Center for Diabetes, Metabolism and Endocrinology, Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Center for Diabetes, Metabolism and Endocrinology, Kansai Electric Power Hospital
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
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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
Management information
Registered date
| 2013 | Year | 08 | Month | 22 | Day |
Last modified on
| 2013 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013461
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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