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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007051
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Disease Control and Homeostasis,
Kanazawa University Graduate School of Medical Science,
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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