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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004356
Receipt No. R000004828
Scientific Title Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes
Date of disclosure of the study information 2010/10/31
Last modified on 2012/06/02

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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
Last 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
1st 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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