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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010211
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shiraiwa Medical Clinic
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011960

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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