UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021629 |
|---|---|
| Receipt number | R000024946 |
| Scientific Title | Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2017/09/27 09:08:41 |
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Basic information
Public title
Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial
Acronym
Efficacy and safety of IDegAsp switching from basal insulin
Scientific Title
Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial
Scientific Title:Acronym
Efficacy and safety of IDegAsp switching from basal insulin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide appropriate insulin dose recommendations when switching from basal insulin to IDegAsp.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in AUC-Glu during test meal loading before and after switching from basal insulin to IDegAsp
Key secondary outcomes
Change from baseline in insulin dose (U) after 4 weeks of treatment
Changes from baseline in FPG, GA, and 1,5-AG after 4 weeks of treatment
Beta-cell stress assessed by the change of plasma intact proinsulin / C-peptide ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
basal insulin
Interventions/Control_2
IDegAsp
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
Outpatients
Current oral antidiabetic drug(s) treatment with Iglar or IDeg
7.0% <= HbA1c <= 9.0%
BMI <=35 kg/m2
Key exclusion criteria
The exclusion criteria were pregnancy, severe illness, CKD (eGFR < 30 ml/min/1.73m2), and malignancy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
smu.tainai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Nagai |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
ynagai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/jdi.12748/epdf
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
| 2016 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024946
