UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes
Acronym	effect of thrice daily aspart 70/30 on type 2 diabetes
Scientific Title	Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes
Scientific Title:Acronym	effect of thrice daily aspart 70/30 on type 2 diabetes
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of thrice daily Aspert and thrice daily Aspert 70/30 on glycemic control and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	comparison of glycemic control(HbA1c, BSDP monitored by SMBG, and safety (frequency of hypoglycemia)
Key secondary outcomes	influence on atheregenic infectious marker and total dose of daily insulin

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	thrice daily biphasic insulin aspart 70/30
Interventions/Control_2	thrice daily ultra-rapid insulin aspart
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	1)Type 2 diabetes patients whose glycated hemoglobin level are between 6.5 and 8.0 % 2)glycated hemoglobin level were stable during last three months (-0.5 to 0.5%) 3)subjects who are already performing diet and exercise therapy for 6 months 4)subjects who were prescribed only ultra rapid insulin thrice daily for more than 6 months 5)no ristriction on the drugs already prescribed but no allowance to stop them or change the doses of them. It is possible to change those to avoid adverse effects like hypoglycemia 6)subjcets whose age are more than 20 years. 7)no restriction on gender 8)subjects who chan understand informed consent
Key exclusion criteria	1) type 1 diabetes 2) patients who have serious liver disease (AST and/or ALT are more than 100IU/L) 3) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL) 4) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months) 5) patients who have serious pancreatic disease 6) patients with cancer 7) anemic patients (Hb is less than 11g/dL) 8) patients with thrombocytepenia (Platelet count is less than 100000/mm3) 9) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy 10) patietns with serious infection, inflammation, or injuary. pre- or post- operative state 11) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus 12) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome 13) patients who has the disease which is deteriorated with increase of gas in bowel 14) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day) 15) patients who are pregnant, hope to be pregnant, or are in lactation period 16) patients who have viral infection (HBV,HCV) 17) patients who are not applicable to this study judged by the medical doctor.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahisa Hirose
Organization	Juntendo University Graduate School of Medicine
Division name	Dept of Medicine, Metabolism and Endocrinology
Zip code
Address	2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Juntendo University Graduate School of Medicine
Division name	Dept of Medicine, Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email	hirosemd@juntendo.ac.jp

Sponsor
Institute	Dept of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
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 31 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	2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 10 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	2010 Year 10 Month 07 Day
Last modified on	2012 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004828

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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