UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003503 |
|---|---|
| Receipt number | R000004012 |
| Scientific Title | An open label, randomized control study for the comparison of effectiveness between Alfa-Glucosidase inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes treated diet therapy and/or single oral hypoglycemic agent |
| Date of disclosure of the study information | 2010/04/21 |
| Last modified on | 2015/08/14 15:01:57 |
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Basic information
Public title
An open label, randomized control study for the comparison of effectiveness between Alfa-Glucosidase inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes treated diet therapy and/or single oral hypoglycemic agent
Acronym
An open label, randomized control study for the comparison of effectiveness between Alfa-Glucosidase inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes treated diet therapy and/or single oral hypoglycemic agent
Scientific Title
An open label, randomized control study for the comparison of effectiveness between Alfa-Glucosidase inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes treated diet therapy and/or single oral hypoglycemic agent
Scientific Title:Acronym
An open label, randomized control study for the comparison of effectiveness between Alfa-Glucosidase inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes treated diet therapy and/or single oral hypoglycemic agent
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the effects of sitagliptin on metabolic and cardiovascular parameters and the effect for peristalsis in people with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1C
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin 50mg once a day for 12 weeks.
However for mild renal failure, once-daily sitagliptin 25mg for 12 weeks
Interventions/Control_2
voglibose 0.2mg three times a day, at the start of each main meal
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
1)Type 2 diabetes
2)HbA1c >=6.5% during 8 weeks prior to the study
3)Treated with none or single oral hypoglycemic agent(OHA:SU,BG,TZD) over 12 weeks prior to the study
Key exclusion criteria
1.None Type 2 diabetes
2.Medical history and/or complication of diabetic ketoacidosis
3.Medical history and/or complication of severe hypoglycemia
4.Insulin treatment within 16 weeks prior to the study
5.Treatment with Alfa-glucosidase inhibitors or sitagliptin within 12 weeks prior to the study
6.Treatment with glucocorticoid
7.Unstable glycemic contol
8.Hypersensitivity to or contraindication of sitagliptin and voglibose
9.AST or ALT >=2.5 time of institutional upper normal limit
10.Uncontrolled hypertension(systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
11.Severe health problems not suitable for the study
12.Pregnant or lactating women
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAMURA Toshinari |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumie Takeshita |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
NPO-HEART
Organization
Division
Category of Funding Organization
Non profit foundation
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
市立敦賀病院（福井県）、もりやま越野病院（石川県）、半田内科医院（石川県）、石田病院（石川県）、加登病院（石川県）、やわたメディカルセンター（石川県）、富山県立中央病院（富山県）、富山市民病院（富山県）、市立砺波総合病院（富山県）、能登総合病院（石川県）、金沢医療センター（石川県）、金沢市立病院（石川県）、金沢赤十字病院（石川県）、 公立松任石川中央病院（石川県）、河北中央病院（石川県）、公立羽咋病院（石川県）、福井済生会病院（福井県）、T’sクリニック（石川県）、米島内科医院（石川県）、
ふじもとクリニック（石川県）、早川浩之の内科医院（石川県）、大野内科医院（石川県）、香川大学医学部附属病院内分泌代謝内科（香川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 21 | 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
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 07 | 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
| 2010 | Year | 04 | Month | 18 | Day |
Last modified on
| 2015 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004012
