UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009627 |
|---|---|
| Receipt number | 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 20:57:58 |
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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
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
kurodaakio@tokushima-u.ac.jp
Sponsor or person
Institute
Diabetes Therapeutics and Research Center, The University of Tokushima
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011293
