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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009627
Receipt No. R000011293
Scientific Title The comparison of blood glucose profile of diabetic patients who change Insulin Glargine to Insulin Degludec as basal insulin.
Date of disclosure of the study information 2013/03/01
Last modified on 2013/12/25

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Basic information
Public title The comparison of blood glucose profile of diabetic patients who change Insulin Glargine to Insulin Degludec as basal insulin.
Acronym The comparison of blood glucose profile when basal insulin is swiched to insulin degludec in clinical setting.
Scientific Title The comparison of blood glucose profile of diabetic patients who change Insulin Glargine to Insulin Degludec as basal insulin.
Scientific Title:Acronym The comparison of blood glucose profile when basal insulin is swiched to insulin degludec in clinical setting.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare blood glucose profile when basal insulin is changed from insulin glargine to insulin degludec in patients with diabetes.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Hypoglycemia frequency and insulin degludec requirement during 2 months after switching from insulin glargine.
Key secondary outcomes Body weight change, clinical parameters, and other side effects 2 months after switching from insulin glargine.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Participants were treated with insulin glargine for two days. Insulin glargine was replaced to insulin degludec with same insulin dosage on the third day. CGM was recorded from the start of the study period until the third day after the replacement with insulin degludec. Degludec dose was titrated to adjust target blood glucose. Degludec treatment continued for 2 months.
Interventions/Control_2
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 The patients with diabetes, who are on insulin glargine treatment, whose glargine dose was titrated to adjust bedtime and prebreakfast blood glucose equally (<30mg/dl).
Key exclusion criteria 1. Patients who cannot record their blood glucose results.
2. Patients who cannot come to the clinic regularly.
3. Patients who are not allowed to keep good blood glucose management.
4. Patients who are considered tobe inappropriate for this trial by the physician.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Munehide Matsuhisa
Organization The University of Tokushima
Division name Diabetes Therapeutics and Research Center
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, 770-8503 Japan
TEL +81-88-633-7587
Email matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Kuroda
Organization The University of Tokushima
Division name Diabetes Therapeutics and Research Center
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, 770-8503 Japan
TEL +81-88-633-7587
Homepage URL
Email kurodaakio@tokushima-u.ac.jp

Sponsor
Institute Diabetes Therapeutics and Research Center, The University of Tokushima
Institute
Department

Funding Source
Organization The University of Tokushima, Diabetes Therapeutics and Research Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Terasawa Hospital
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
2013 Year 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 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
2012 Year 12 Month 25 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011293

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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