UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006630 |
|---|---|
| Receipt number | R000007806 |
| Scientific Title | Compare the add-on effects in glycemic control and durability of sitagliptin and alfa-glucosidase inhibitor uncontrolled with metformin monotherapy. |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2011/10/29 20:38:48 |
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Basic information
Public title
Compare the add-on effects in glycemic control and durability of sitagliptin and alfa-glucosidase inhibitor uncontrolled with metformin monotherapy.
Acronym
Choice trial
Scientific Title
Compare the add-on effects in glycemic control and durability of sitagliptin and alfa-glucosidase inhibitor uncontrolled with metformin monotherapy.
Scientific Title:Acronym
Choice trial
Region
| Japan |
Condition
Condition
typw2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the new treatment strategy for Japanese type 2 diabetes, compare the add-on effects in glycemic control and durability of sitagliptin and alfa-glucosidase inhibitor uncontrolled with metformin monotherapy.
And more, investigate the potential of metformin monotherapy which is low cost and has cost-effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
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
sitagliptin
Interventions/Control_2
alfa-glucosidase inhibitor
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,Type 2 diabetes whose HbA1c is>6.0% and <8.7%(JDS) under lifestyle intervention and metformin monotherapy
2,80>Age>19(Male and female)
3,Written informed consent by patients
Key exclusion criteria
1. Patients who had diabetic ketoacidosis, or diabetic pre- and coma within 6 months of the study entry.
2. Patients who received surgery operation during the study.
3. Patients with pregnancy or Nursing mothers
4. Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5. Patients who received insulin or GLP-1 analog therapy
6. Patients who received any oral diabetic therapy(exclusive metformin)
7. Patients who had a history of hypersensitivity reaction to sitagliptin
8. Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Morimoto |
Organization
Saitama social insurance hospital
Division name
Internal medicine
Zip code
Address
8-9-3 Kitaurawa, Urawa-ku, Saitama-shi, Saitama prefecture, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama social insurance hospital
Division name
Internal medicine
Zip code
Address
TEL
Homepage URL
jiromt2@kxb.biglobe.ne.jp
Sponsor or person
Institute
Saitama social insurance hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 29 | Day |
Last modified on
| 2011 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007806
