UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007051 |
|---|---|
| Receipt number | R000008067 |
| Scientific Title | Switch to oral hypoglycemic agent therapy from insulin injection |
| Date of disclosure of the study information | 2012/01/11 |
| Last modified on | 2012/01/11 16:10:43 |
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Basic information
Public title
Switch to oral hypoglycemic agent therapy from insulin injection
Acronym
Switch to oral hypoglycemic agent therapy from insulin injection
Scientific Title
Switch to oral hypoglycemic agent therapy from insulin injection
Scientific Title:Acronym
Switch to oral hypoglycemic agent therapy from insulin injection
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Switch from insulin therapy to oral agents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Nadir FPG
Key secondary outcomes
HbA1c
lipid profile
safety
etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Mitiglinide
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) men and women with type 2 diabetes (aged >20);
(2) modelately controlled diabetes with the change of HbA1c <3% within 12 weeks before screening;
(3) insulin dosage of less than 60 units/24 h.
Key exclusion criteria
(1) had hypersensitivity or a contraindication to mitiglinide or sitagliptin; (2) had a history of type 1 diabetes or a history of ketoacidosis; (3) experienced repeated episodes of unexplained hypoglycaemia as defined by FPG or without the symptoms of hypoglycaemia or <60 mg/dl with symptoms of hypoglycaemia; (4) concomitantly suffering from infection and planning to have surgery; (5) treatment with a mitiglinide, and a sitagliptin within 12 weeks before screening; (6) concomitant corticosteroid therapy; (7) poorly controlled diabetes; (8) under dialysis and serum creatinine >2.5 mg/dl in men or >2.0 mg/dl in women; (9) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2.5-fold the upper limit of normal; (10) poorly controlled hypertensions or systolic blood pressure>160 mmHg, or diastolic blood pressure>100 mmHg; (11) currently and/or previously suffering from heart failure; (12) severe retinopathy; (13) malignancy on active therapeutic regimen or without complete remission or cure; (14) pregnancy or breast feeding; (15) inadequacy to participate in the study, as assessed by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari Takamura |
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 920-8641, Japan
TEL
076-265-2234
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
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 920-8641, Japan
TEL
076-265-2234
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
Department of Disease Control and Homeostasis,
Kanazawa University Graduate School of Medical Science,
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 01 | Month | 11 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 11 | Day |
Last modified on
| 2012 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008067
