UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004259 |
|---|---|
| Receipt number | R000005110 |
| Scientific Title | Comparative study for glycemic control and adherence when adding DPP-4 inhibitor alogliptin to patients with type 2 diabetes who had been treated with three times administration of alpha-glucosidase inhibitors but still in poor glycemic control by maintaining, reducing, or stopping the administration of alpha-glucosidase inhibitors. |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2010/09/24 12:39:36 |
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Basic information
Public title
Comparative study for glycemic control and adherence when adding DPP-4 inhibitor alogliptin to patients with type 2 diabetes who had been treated with three times administration of alpha-glucosidase inhibitors but still in poor glycemic control by maintaining, reducing, or stopping the administration of alpha-glucosidase inhibitors.
Acronym
alpha-GI0,1,2,3+alogliptin
Scientific Title
Comparative study for glycemic control and adherence when adding DPP-4 inhibitor alogliptin to patients with type 2 diabetes who had been treated with three times administration of alpha-glucosidase inhibitors but still in poor glycemic control by maintaining, reducing, or stopping the administration of alpha-glucosidase inhibitors.
Scientific Title:Acronym
alpha-GI0,1,2,3+alogliptin
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare glycemic control and adherence when adding 25 mg of DPP-4 inhibitor alogliptin to patients with type 2 diabetes who had been treated with three times administration of alpha-glucosidase inhibitors but still in poor glycemic control by maintaining, reducing (twice or once), or stopping the administration of alpha-glucosidase inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
HbA1c, glycoalbumin
Key secondary outcomes
Body weight, adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taking alogliptin only
Interventions/Control_2
Taking alpha-GI once a day in addition to alogliptin
Interventions/Control_3
Taking alpha-GI twice a day in addition to alogliptin
Interventions/Control_4
Taking alpha-GI thrice a day in addition to alogliptin
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Type 2 Diabetic patients
2.Patients who are taking alpha-GI thrice a day.
3.HbA1c <JDS> level at baseline 6.5-9.0%
4.Subjects who provided written informed consent.
Key exclusion criteria
1. Patients who are receiving insulin therapy.
2. Patients who are taking anti-diabetic medicines other than alpha-GI
3. Patients who have a severe hepatic dysfunction.
4. Patients who have a severe renal dysfunction
5. Patients whose doctor in charge judges as inappropriate for the inclusion
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2639
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyomi Masuda |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2639
Homepage URL
t086051a@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
横浜市立大学附属病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 24 | Day |
Last modified on
| 2010 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005110
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