UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010447 |
|---|---|
| Receipt number | R000012216 |
| Scientific Title | Comparison of ultralongacting insulin, glargine and degludec in type2 diabetes |
| Date of disclosure of the study information | 2013/04/09 |
| Last modified on | 2017/04/17 10:34:44 |
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Basic information
Public title
Comparison of ultralongacting insulin, glargine and degludec in type2 diabetes
Acronym
Comparison of ultralongacting insulin, glargine and degludec
Scientific Title
Comparison of ultralongacting insulin, glargine and degludec in type2 diabetes
Scientific Title:Acronym
Comparison of ultralongacting insulin, glargine and degludec
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effect of glargine and degludec on glycemic control and safety in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Achievement rate of FPG <110mg/dl and PPG <180mg/dl after treatment with glargine or degludec
Key secondary outcomes
1)Glucose variability, CV.
2)Achievment rate of <110mg/dl of FPG or 180mg/dl of PPG
3)FPG and PPG after 2 weeks of treatment
4)days to achieve target
5)frequencies of hypoglycemia
6)Achievment rate of <130mg/dl of FPG or 200mg/dl of PPG
7)lipid control
8)MAGE and CV in CGM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
degludec 4units/day and Quick insulin 4units every meals,then doses of insulin is adjusted according to the algorythm.
Interventions/Control_2
Glargine 4units/day
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)before test registration - no insulin therapy and inpatient
2)FPG :more than 200mg/dl, PPG:more than 300mg/dl
3)HbA1c :more than 8.0%, less than 14%
4)Type 2 diabetes
5)Age more than 20, less than 85Type
6)Pts with written IC
Key exclusion criteria
1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)severe hepatic dysfunction
4)or severe renal dysfunction (SCr:more than 2.0mg/dl or eGFR less than 30)
5)pregnacy
6)Allergy for glargine and degludec
7)Patients judged by the investigator to be ineligible for some other reason
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
yamakat@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Suzuki |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
jsuzuki@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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)
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
横浜市立大学附属市民総合医療センター（神奈川県）
藤沢市民病院(神奈川県)
横須賀市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 09 | 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
| 2013 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012216
