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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010311
Receipt No. R000012068
Scientific Title Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Date of disclosure of the study information 2013/03/25
Last modified on 2017/09/26

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Basic information
Public title Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Acronym Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Scientific Title Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Scientific Title:Acronym Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Region
Japan

Condition
Condition T2DM
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the optimal oral hypoglycemic agent (OHA) added to thrice-daily pre-meal biphasic insulin aspart 70 (BIAsp70) in Japanese type 2 diabetic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Pre-breakfast blood glucose
2) Average of the blood glucose
3) Variability of the blood glucose
Key secondary outcomes Frequency of hypoglycemia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BIAsp70
Interventions/Control_2 Addition of glimepiride (0.5 mg/day) to the BIAsp70
Interventions/Control_3 Addition of metformin (500 mg/day) to the BIAsp70
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
80 years-old >=
Gender Male and Female
Key inclusion criteria T2DM
Key exclusion criteria 1. Pregnant or intention of becoming pregnant

2. Patients who are judged by investigators to be inappropriate for inclusion in the study
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Nagai
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
Homepage URL
Email

Sponsor
Institute St. Marianna University 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
2013 Year 03 Month 25 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
2011 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 24 Day
Last modified on
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012068

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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