UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019886 |
|---|---|
| Receipt number | R000022974 |
| Scientific Title | The comparison of basal insulin therapy with average daily risk range (ADRR). |
| Date of disclosure of the study information | 2015/11/21 |
| Last modified on | 2015/11/21 11:01:21 |
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Basic information
Public title
The comparison of basal insulin therapy with average daily risk range (ADRR).
Acronym
The comparison of basal insulin therapy with average daily risk range (ADRR).
Scientific Title
The comparison of basal insulin therapy with average daily risk range (ADRR).
Scientific Title:Acronym
The comparison of basal insulin therapy with average daily risk range (ADRR).
Region
| Japan |
Condition
Condition
Patients with diabetes melliutus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the effect of basal insulin degludec and glargine for diabetic patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADRR
Key secondary outcomes
SMBG
HbA1c
1.5AG
Body weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin glargine group
Insulin glargine-treated patients continued to receive glargine on a fasting blood glucose target of <120mg/dL.
Interventions/Control_2
Insulin degldec group
1.The patients initially changed glargine to degludec.
2.After the changing, patients received degldec for 12 weekson a fasting blood glucose target of < 120 mg/dL.
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
Insulin glargine-treated patients with type 1 and 2 diabetes.
Key exclusion criteria
1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry.
2. Patients with during pregnancy or lactation.
3. severe infection, before operation, severe trauma
4. Patients who received steroid therapy
5. Patients with history of cardiac failure.
6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min).
7. Patients with severe liver dysfunction.
8. Patients who are hypersensitive to these medicines
9.Patients judged to be inappropriate by physicians in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ito |
Organization
Machida Municipal Hospital
Division name
Diabetes and endocrine internal medicine
Zip code
Address
2-15-41 Asahi-machi Machida city Tokyo
TEL
042-722-2230
s.itou@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ito |
Organization
Machida Municipal Hospital
Division name
Diabetes and endocrine internal medicine
Zip code
Address
2-15-41 Asahi-machi Machida city Tokyo
TEL
042-722-2230
Homepage URL
s.itou@machida-city-hp.jp
Sponsor or person
Institute
MACHIDA MUNICIPAL HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
MACHIDA MUNICIPAL HOSPITAL
Organization
Division
Category of Funding Organization
Local Government
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
町田市民病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 21 | Day |
Last modified on
| 2015 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022974
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
