UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005194 |
|---|---|
| Receipt number | R000006168 |
| Scientific Title | Comparison between long acting insulin analogue and biphasic insulin aspart30/70 (BIAsp 30) as combination therapy with oral anti-diabetic agents. |
| Date of disclosure of the study information | 2011/03/04 |
| Last modified on | 2011/03/04 19:40:56 |
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Basic information
Public title
Comparison between long acting insulin analogue and biphasic insulin aspart30/70 (BIAsp 30) as combination therapy with oral anti-diabetic agents.
Acronym
Comparison between long acting insulin analogue and biphasic insulin aspart30/70 (BIAsp 30)
Scientific Title
Comparison between long acting insulin analogue and biphasic insulin aspart30/70 (BIAsp 30) as combination therapy with oral anti-diabetic agents.
Scientific Title:Acronym
Comparison between long acting insulin analogue and biphasic insulin aspart30/70 (BIAsp 30)
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of long acting insulin analogues and biphagic insulin aspart 30/70 (BIAsp 30) as combination therapy with oral anti-diabetic agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The level of HbA1cand 1,5-AG.
Mean value and coefficient of variance (CVs) obtained from SMBG
Key secondary outcomes
body weight and the 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Changing from long ancting insurlin analogue to BIAsp 30 without changing the dose of oral anti-diabetic agents.
After 3 months of BIAsp 30 therapy, reconversion from BIAsp 30 to long ancting insurlin analogue.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients treated with BOT using long acting insulin analogues
Key exclusion criteria
Patients wiht severe liver or renal injury.
Patients in the perioperative period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhito Tone |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL
+81-86-294-9911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhito Tone |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL
+81-86-294-9911
Homepage URL
aitone@okayama3.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
国立病院機構 岡山医療センター(岡山県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 04 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | 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
| 2011 | Year | 03 | Month | 04 | Day |
Last modified on
| 2011 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006168
