UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004396 |
|---|---|
| Receipt number | R000005218 |
| Scientific Title | A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy. |
| Date of disclosure of the study information | 2010/10/16 |
| Last modified on | 2014/04/16 14:17:46 |
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Basic information
Public title
A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy.
Acronym
Once-J Study
Scientific Title
A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy.
Scientific Title:Acronym
Once-J Study
Region
| Japan |
Condition
Condition
Type 2 DM
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison the efficacy and the safety using continuous glucose monitoring (CGM) of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese patients with type 2 diabetes mellitus on monotherapy or combination therapy with sulfonylureas, biguanides and thiazolidinediones.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24 hour glycemic variations using CGM
Change of HbA1c value
Frequency of hypoglycemia during an observation period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once-daily insulin detemir
Interventions/Control_2
Once-daily biphasic insulin aspart-30
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consent of the participation to this study by a document.
More than three months since subjects were diagnosed as Type 2 diabetes mellitus.
Not having insulin treatment within six months.
HbA1c>8.0%,<10%
BMI<30kg/m2
Monotherapy or combination therapy with oral hypoglycaemic agents
(Sulfonylureas,Thiazolidinediones,Biguanides).
Key exclusion criteria
Hypoglycemia
Insulin allergy
having participated in this study in the past
amount of medicine for usage out of an authorized use
Severe retinopathy
Pregnancy
Nursing
Past using Alpha-GIs or Glinides within two months
In addition, Medical attendants judged not to be appropriate as a subject of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL
03-3433-1111(3243)
rimei@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Tsujino |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL
03-3433-1111(3243)
Homepage URL
dtsujino7777@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
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
| 2010 | Year | 10 | Month | 16 | 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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 18 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 16 | Day |
Last modified on
| 2014 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005218
