UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025199 |
|---|---|
| Receipt number | R000028989 |
| Scientific Title | The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2019/04/09 16:08:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients
Acronym
The efficacy of insulin degludec/insulin aspart switching from existing long acting insulin in type 2 diabetes patients
Scientific Title
The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients
Scientific Title:Acronym
The efficacy of insulin degludec/insulin aspart switching from existing long acting insulin in type 2 diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess postprandial blood glucose, HbA1c and incidence rate of hypoglycemia by insulin degludec/insulin aspart compared with insulin degludec or insulin glargine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Difference between pre-prandial blood glucose level and postprandial blood glucose level in main meal measured by SMBG at 12 weeks after intervention.
Key secondary outcomes
1) Glucose variability measured by SMBG
2) Blood and urine test (including HbA1c)
3) Body weight
4) Incidence rate of hypoglycemia
5) Dose of insulin and other antidiabetic agent
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Keeping insulin degludec or insulin glargine
Interventions/Control_2
Switching from insulin degludec or insulin glargine to insulin degludec/insulin aspart
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who were 20-year-old to 80-year-old at the time of obtaining informed consent
2) Patients whose HbA1c level is more than 6.0% and less than 9.0% at the time of obtaining informed consent
3) Patients who were taking insulin degludec or insulin glargine once daily more than three months and measuring their blood glucose by SMBG
4) Patients who are able to understand the study and willing to provide written informed consent
Key exclusion criteria
1) Patients with hypersensitivity to insulin degludec/ insulin aspart
2) Patients with severe or unstable retinopathy
3) Patients with severe liver or kidney dysfunction
4) Patients with pregnancy
5) Patients with severe diabetic ketosis, diabetic coma
6) Patients who are obviously bad adherence of diet.
7) Patients who needs intensive insulin therapy due to whose insulin depletion
8) Patients who are deemed to be unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Hokkaido University
Division name
Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine
Zip code
060-8638
Address
n15, w7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-8192
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University Hospital
Division name
Department of Medicine 2/Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
n14, w5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7735
Homepage URL
kyuyong-cho@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self founding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
n14w5, kita-ku, Sapporo, Hokkaido, Japan
Tel
011-701-7636
crjimu@huhp.hokudai.ac.jp
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
北海道大学病院(北海道)、青木内科クリニック(北海道)、沖医院(北海道)、釧路赤十字病院(北海道)、栗原内科(北海道)、栗山赤十字病院(北海道)、苫小牧市立病院(北海道)、北海道せき損センター(北海道)、北海道中央労災病院(北海道)、萬田記念病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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
60
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
| 2016 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028989
