UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010211 |
|---|---|
| Receipt number | R000011960 |
| Scientific Title | Effect of high-dose DPP-4 inhibitor or single-dose rapid-acting insulin on glycemic control in type 2 diabetic patients treated with regular-dose DPP-4 inhibitor and long-acting insulin |
| Date of disclosure of the study information | 2013/03/26 |
| Last modified on | 2013/10/25 12:40:11 |
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Basic information
Public title
Effect of high-dose DPP-4 inhibitor or single-dose rapid-acting insulin on glycemic control in type 2 diabetic patients treated with regular-dose DPP-4 inhibitor and long-acting insulin
Acronym
High-dose DPP-4 inhibitor versus single-dose rapid-acting insulin in BOT
Scientific Title
Effect of high-dose DPP-4 inhibitor or single-dose rapid-acting insulin on glycemic control in type 2 diabetic patients treated with regular-dose DPP-4 inhibitor and long-acting insulin
Scientific Title:Acronym
High-dose DPP-4 inhibitor versus single-dose rapid-acting insulin in BOT
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect on glycemic control between high-dose sitagliptin and single-dose insulin glulisine in type 2 diabetic patients who are treated with regular-dose sitagliptin and long-acting insulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control assessed with self-monitoring of blood glucose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To increase the dose of sitagliptin to 100 mg per day
Interventions/Control_2
To initiate the single-dose administration of insulin glulisine
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
Patients under the combination therapy of sitagliptin and long-acting insulin
Key exclusion criteria
- severe hepatic, renal, and/or cardiac disease
- hypersensitivity to the drug using in the study
- pregnant or breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shiraiwa |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
1-12-8 Hirano, Kashiwara City, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
1-12-8 Hirano, Kashiwara City, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Shiraiwa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Depertment of Metabolic Medicine, Osaka University Graduate School of Medicine
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 | 26 | 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
| 2013 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 26 | 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
| 2013 | Year | 03 | Month | 11 | Day |
Last modified on
| 2013 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011960
