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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019886
Receipt No. R000022974
Scientific Title The comparison of basal insulin therapy with average daily risk range (ADRR).
Date of disclosure of the study information 2015/11/21
Last modified on 2015/11/21

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Basic information
Public title The comparison of basal insulin therapy with average daily risk range (ADRR).
Acronym The comparison of basal insulin therapy with average daily risk range (ADRR).
Scientific Title The comparison of basal insulin therapy with average daily risk range (ADRR).
Scientific Title:Acronym The comparison of basal insulin therapy with average daily risk range (ADRR).
Region
Japan

Condition
Condition Patients with diabetes melliutus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examined the effect of basal insulin degludec and glargine for diabetic patient.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADRR
Key secondary outcomes SMBG
HbA1c
1.5AG
Body weight

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Insulin glargine group
Insulin glargine-treated patients continued to receive glargine on a fasting blood glucose target of <120mg/dL.
Interventions/Control_2 Insulin degldec group
1.The patients initially changed glargine to degludec.
2.After the changing, patients received degldec for 12 weekson a fasting blood glucose target of < 120 mg/dL.
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 Insulin glargine-treated patients with type 1 and 2 diabetes.
Key exclusion criteria 1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry.
2. Patients with during pregnancy or lactation.
3. severe infection, before operation, severe trauma
4. Patients who received steroid therapy
5. Patients with history of cardiac failure.
6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min).
7. Patients with severe liver dysfunction.
8. Patients who are hypersensitive to these medicines
9.Patients judged to be inappropriate by physicians in charge.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoshi Ito
Organization Machida Municipal Hospital
Division name Diabetes and endocrine internal medicine
Zip code
Address 2-15-41 Asahi-machi Machida city Tokyo
TEL 042-722-2230
Email s.itou@machida-city-hp.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Satoshi Ito
Organization Machida Municipal Hospital
Division name Diabetes and endocrine internal medicine
Zip code
Address 2-15-41 Asahi-machi Machida city Tokyo
TEL 042-722-2230
Homepage URL
Email s.itou@machida-city-hp.jp

Sponsor
Institute MACHIDA MUNICIPAL HOSPITAL
Institute
Department

Funding Source
Organization MACHIDA MUNICIPAL HOSPITAL
Organization
Division
Category of Funding Organization Local Government
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 町田市民病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 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 Enrolling by invitation
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 Day
Last follow-up date
2017 Year 11 Month 20 Day
Date of closure to data entry
2017 Year 11 Month 20 Day
Date trial data considered complete
2017 Year 11 Month 20 Day
Date analysis concluded
2017 Year 11 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 21 Day
Last modified on
2015 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022974

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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