UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009544 |
|---|---|
| Receipt number | 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 09:10:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
