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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005129
Receipt No. R000006089
Scientific Title Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30
Date of disclosure of the study information 2011/02/23
Last modified on 2011/02/23

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Basic information
Public title Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30
Acronym Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30
Scientific Title Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30
Scientific Title:Acronym Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30
Region
Japan

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

Objectives
Narrative objectives1 Biphasic insulin aspart 30 (BIAsp30) has an earlier and stronger peak effect with a similar duration of action to biphasic human insulin 30 (BHI30). However, direct comparison of daily glucose excursion during treatment with these two types of insulin has not been done.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of CGM Parameters and Data Analysis
After downloading the recorded data, the following parameters were analyzed from the intermediate 48 hours of data: average glucose level (AG), standard deviation (SD) of glucose, mean amplitude of glucose excursion (MAGE), area under the glucose curve (AUC-glu) during the 30-min period before each meal, at 1-2 hour, 2-3 hour, and 3-4 hour after each meal, and during the night (10PM to 7AM), and area under the curve of incremental (baseline-corrected) postprandial glucose from just before to 4 hours after each meal (IAUC0-4h).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
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 BIAsp30 to BHI30
After enrollment, patients were randomized to the BIAsp30 group or BHI30 group. Then, sulfonylurea therapy was suspended and insulin was started twice daily (before breakfast and dinner) at the outpatient clinic. BIAsp30 and BHI30 were injected just before meals and 30 min before meals, respectively. The insulin dosage was adjusted to achieve individual target levels, which were set by the attending physician considering each patients clinical condition.
Interventions/Control_2 BHI30 to BIAsp30
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
80 years-old >=
Gender Male and Female
Key inclusion criteria type2 DM
Inclusion criteria were stable but inadequate glycemic control (HbA1c>7.8% and variation of HbA1c by <0.5% within 3 months before enrollment) and treatment with a sulfonylurea only (not insulin with or without other oral antidiabetic agents).
Key exclusion criteria The exclusion criteria included pregnancy, severe medical illnesses, anemia, renal failure (serum creatinine>2.0 mg/dl), overt proteinuria, chronic liver disease, thyroid disease, malignancy, or severe hypoglycemia requiring assistance within the previous 6 months.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Ohta
Organization St. Marianna University School of Medicine
Division name Department of Internal Medicine, Division of Metabolism and Endocrinology
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
Organization St. Marianna University School of Medicine
Division name Department of Internal Medicine, Division of Metabolism and Endocrinology
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 No source
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
2011 Year 02 Month 23 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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2011 Year 02 Month 23 Day
Last modified on
2011 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006089

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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