UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004744 |
|---|---|
| Receipt number | R000005649 |
| Scientific Title | Comparison of 24-hour glycemic excursions in patients with type 2 diabetes receiving additional anti-diabetic agents, acarbose versus sitagliptin, by using continuous glucose monitoring (CGM) |
| Date of disclosure of the study information | 2010/12/17 |
| Last modified on | 2011/06/17 17:18:30 |
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Basic information
Public title
Comparison of 24-hour glycemic excursions in patients with type 2 diabetes receiving additional anti-diabetic agents, acarbose versus sitagliptin, by using continuous glucose monitoring (CGM)
Acronym
Acarbose versus sitagliptin, by using continuous glucose monitoring (CGM)
Scientific Title
Comparison of 24-hour glycemic excursions in patients with type 2 diabetes receiving additional anti-diabetic agents, acarbose versus sitagliptin, by using continuous glucose monitoring (CGM)
Scientific Title:Acronym
Acarbose versus sitagliptin, by using continuous glucose monitoring (CGM)
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate 24-hour glycemic excursions by using CGM and to analyze changes in blood glucose profile of the subjects when receiving additional anti-diabetic agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the parameters related to glucose profile of the subjects when receiving additional anti-diabetic agents(average glucose, maximum and minimum glucose, area under the curve, standard deviation, mean amplitude of glycemic excursions)
Key secondary outcomes
Frequency of hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
day1 conventional therapy
day2 Addition of acarbose(300 mg/day) to the conventional therapy
day3 Addition of sitagliptin (50 mg/day) to the conventional therapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who were admitted into the Yokohama-City University Hospital
Key exclusion criteria
1,Subjects who have already been treated with insuln, alfa-glucosidase inhibitor or DPP4 inhibitor.
2,Subjects who are hypersensitive to this medicine and/or contaminants of this medicine.
3,Any condition that the investigator considers a potential obstacle to trial participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2639
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Kikuchi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2639
Homepage URL
t086028f@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Department of Endocrinology & Metabolism
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Department of Endocrinology & Metabolism
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
| 2010 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 17 | Day |
Last modified on
| 2011 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005649
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| Registered date | File name |
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| Registered date | File name |
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