UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007375 |
|---|---|
| Receipt number | R000008687 |
| Scientific Title | Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs |
| Date of disclosure of the study information | 2012/02/27 |
| Last modified on | 2012/02/24 17:18:24 |
* 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
Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs
Acronym
Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs
Scientific Title
Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs
Scientific Title:Acronym
Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the effects of glycaemic control and frequency of hypoglycemia to treat with once daily injection of insulin glargine add to OADs those who inadequately controlled with several OADs containing DPP4 inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of HbA1c
Reduction of FPG
Key secondary outcomes
Achievement ratio of HbA1c below 6.5 and 7.0%.
Change of BW
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add once daily injection of insulin glargine before breakfast
Starting dose will be 2~20 unit and titrated according to FPG when the patients visit
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients who were treated with OADs containing DPP4 inhibitor with HbA1c 7.0%<=HbA1c<10.0,
Who can measure FPG before breakfast by SMBG
Key exclusion criteria
Exclusion Criteria:
1) Patients except type 2 diabetic patients.
2) Patients taking Probucol, vitamin E and/or vitamin C.
3) Alcoholic,or heavy drinker.
4) Patients operated malignant and gastro extraction.
5) Patients with serious complications of DM.
Nephropathy:*. Retinopathy:**
6) Drug anaphylaxis patient.
7) Pregnant or patients who plan to carry, or currently breast-feeding woman.
8) Patients who were judged inappropriate to participate in this study by the doctor of study director or cooperative
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Kobayashi |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Medical Uuniversity
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
| 2012 | Year | 02 | Month | 27 | 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
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | 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
| 2012 | Year | 02 | Month | 24 | Day |
Last modified on
| 2012 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
