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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004744
Receipt No. 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

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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
Email

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
Email t086028f@yokohama-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Yokohama City University
Department of Endocrinology & Metabolism
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005649

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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