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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009544
Receipt No. R000011201
Scientific Title Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride
Date of disclosure of the study information 2013/03/31
Last modified on 2012/12/14

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Basic information
Public title Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride
Acronym sitagliptin and glimepiride randomized study
Scientific Title Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride
Scientific Title:Acronym sitagliptin and glimepiride randomized study
Region
Japan

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

Objectives
Narrative objectives1 It is unknown whether sitagliptin dose-up or glimepiride dose-up in combination therapy with sitagliptin and glimepiride is better on glycemic control in subjects with type 2 diabetes. The objective of the study was to compare the efficacy of these treatments in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes % change in HbA1c
Key secondary outcomes % change in BMI, FPB and urinary 8-OHdG

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 +50 mg/day sitagliptin dose-up
Interventions/Control_2 +0.5 mg/day glimepiride dose-up
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

Not applicable
Gender Male and Female
Key inclusion criteria type 2 diabetes treated with sitagliptin (50 mg/day) in addition to glimepiride (<2.0 mg/day) with or without metformin at a stable dosage for at least 16 weeks, aged >20 years, HbA1c level >6.9%, and no improvement in HbA1c within 12 weeks
Key exclusion criteria Subjects with type 1 diabetes, secondary diabetes, severe renal disease, severe hepatic disease, alcoholism, severe depression or severe psychological condition, malignancy or abnormal hemoglobinemia were excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Iwashita
Organization Kumamoto University
Division name Department of Metabolic Medicine, Faculty of Life Sciences
Zip code
Address 1-1-1, Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University
Division name Department of Metabolic Medicine, Faculty of Life Sciences
Zip code
Address 1-1-1, Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
TEL
Homepage URL
Email

Sponsor
Institute Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
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 31 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 Open public recruiting
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 07 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 14 Day
Last modified on
2012 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011201

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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