UMIN-CTR Clinical Trial

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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