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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004396
Receipt No. 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

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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)
Email 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
Email dtsujino7777@gmail.com

Sponsor
Institute The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005218

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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