UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005383 |
|---|---|
| Receipt number | R000006392 |
| Scientific Title | Effect of Miglitol on Glucose Excursion in Japanese Type 2 Diabetic Patients Receiving with Multiple Daily Insulin Injections |
| Date of disclosure of the study information | 2011/04/05 |
| Last modified on | 2011/04/05 18:54:06 |
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Basic information
Public title
Effect of Miglitol on Glucose Excursion in Japanese Type 2 Diabetic Patients Receiving with Multiple Daily Insulin Injections
Acronym
Effect of Miglitol on Glucose Excursion in Japanese Type 2 Diabetic Patients Receiving with Multiple Daily Insulin Injections
Scientific Title
Effect of Miglitol on Glucose Excursion in Japanese Type 2 Diabetic Patients Receiving with Multiple Daily Insulin Injections
Scientific Title:Acronym
Effect of Miglitol on Glucose Excursion in Japanese Type 2 Diabetic Patients Receiving with Multiple Daily Insulin Injections
Region
| Japan |
Condition
Condition
Type 2 Diabetis
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Strict postprandial blood glucose control of may have a preventive effect on atherogenesis in type 2 diabetic patients. Miglitol is known to be useful for controling the early increase of postprandial glucose, but the combined effect of miglitol and multiple daily insulin injections (MDI) on glucose excursion has not been evaluated in type 2 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of adding miglitol to MDI on the daily glucose profile by self-monitoring blood of glucose (SMBG) at nine time points on the day.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
miglitol with multiple daily insulin injections
Interventions/Control_2
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
They were admitted to St. Marianna University Hospital (Kanagawa, Japan) in 2009-2010 for education and improvement of glycemic control, and good glycemic control was achieved by MDI without any alfa-GI or with miglitol. The inclusion criteria were a fasting plasma glucose 140 mg/dl without any symptoms of hypoglycemia throughout the day.
Key exclusion criteria
The exclusion criteria were pregnancy, severe medical illness, chronic liver disease, thyroid disease, malignancy, or a history of abdominal surgery.
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kato |
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
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
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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 | 04 | Month | 05 | 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
| 2007 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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 | 04 | Month | 05 | Day |
Last modified on
| 2011 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006392
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
