UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007487 |
|---|---|
| Receipt number | R000008831 |
| Scientific Title | Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administration |
| Date of disclosure of the study information | 2012/03/20 |
| Last modified on | 2012/03/12 10:34:50 |
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Basic information
Public title
Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administration
Acronym
Blood-Glucose reduction using DPP-4 agents
Scientific Title
Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administration
Scientific Title:Acronym
Blood-Glucose reduction using DPP-4 agents
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify reduction levels of Blood glucose using selective DPP-4 inhibitors, alogliptin 25mg or sitagliptin 50mg administered, respectively for 52-week administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Reduction value of HbA1c level (JDS) at 12, 24, 36, 52 (terminal) if comparing with at 0 (enrolled)
Key secondary outcomes
Fasting blood glucose
Patient rate completed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
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
alogliptin 25mg, tablet, daily, oral
Duration 52 weeks
Interventions/Control_2
sitagliptin 50mg,tablet, daily, oral
Duration 52 weeks
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 patients having Hba1c with more than 6.5% and under 9.0% for 3 months or more using oral anti-DM drug(s) except for selective DPP-4 inhibitors under diet and/or exercise therapy
1. Gender both, 20 years old or more
2. be able to understood fullly, and comply regarding the study protocol
3. Written informed consent taken prior to the enrollment
4. Outpatients
Key exclusion criteria
1. Type 1 diabetes or secondary diabetes
2. Patients with severe infecious disease, operation planned or just after done, and/or serious externalinjyury
3. Other DPP-4 agents users on the enrollement
4. Insulin users
5. Pregnant and possible pregnant, or Lactation
6. AST or ALT 2.5 times or more of normalvalue
7. Serum creatinine2 mg/dL or more
8. Patients with old myocardial infarction, angina pectoris and/or stroke
9. Patients having history of hypersensitivity against study drugs
10.Inappropriate reasons on the enrollment that the physicians/investigators are judged
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Namba |
Organization
Hyogo College of Medicine
Division name
Internal medicine, Diabetes
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya City, Hyogo Pf, 663-8501, Japan
TEL
81-1-798-45-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Usami |
Organization
Biomedis International Ltd
Division name
Study Management
Zip code
Address
ASK Ginza Bldg., 10-6-7 Chuo-ku, Tokyo, 104-0061, Japan
TEL
81-1-3-3575-1611
Homepage URL
hiroko-u@biomedis.co.jp
Sponsor or person
Institute
Biomedis International Ltd
Study Management
Institute
Department
Personal name
Funding Source
Organization
Hyogo Colledge of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
兵庫医科大学(兵庫県）、市立芦屋病院(兵庫県）、県立西宮病院(兵庫県）神戸海星病院(兵庫県）、川崎病院(兵庫県）、協立病院(兵庫県）、渡辺内科クリニック(兵庫県）、
福井医院(兵庫県）、滝内クリニック(兵庫県）、朝田クリニック(兵庫県）
昭和病院(兵庫県）、西宮市立中央病院(兵庫県）、尼崎中央病院(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 20 | 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 | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 12 | Day |
Last modified on
| 2012 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008831
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