UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021046 |
|---|---|
| Receipt number | R000024284 |
| Scientific Title | Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/02/16 07:54:12 |
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Basic information
Public title
Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial
Acronym
Showa university Examines the Effects of Insulin Degludec
Scientific Title
Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial
Scientific Title:Acronym
Showa university Examines the Effects of Insulin Degludec
Region
| Japan |
Condition
Condition
Type 1 and Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare glucose lowering effect of insulin degludec to conventional basal insulin analogue in Japanese patient with type 1 and type 2 diabetes in basal-bolus treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in HbA1c after 16weeks of treatment from baseline
Key secondary outcomes
Hypoglycemic episodes
Change in fasting glucose levels
6-points SMBG profiles
DTSQs scale score
The change in HbA1c after 24weeks of treatment from baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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 degludec(24weeks)
.Initial insulin doses were replased with insulin degludec or conventional basal insulin in a 1:1 ratio(enable the basal insulin dose decrease by the judgment of the investigator)
.The subjects come to the hospital once a month for the duration of treatment and regulate insulin dose based on administration algorithm by the self monitoring of blood glucose(SMBG) level
.Bolus insulin dose adjustment is not given a dose adjustment after administration as much as possible until 16 weeks.(16 weeks later, we allowed to regulate a dose based on administration algorithm)
Interventions/Control_2
.Long-acting insulin analogue other than insulin degludec(24weeks)
.Initial basal insulin doses were replased with insulin degludec or conventional basal insulin in a 1:1 ratio(enable the basal insulin dose decrease by the judgment of the investigator)
.The subjects come to the hospital once a month for the duration of treatment and regulate insulin dose based on administration algorithm by the self monitoring of blood glucose(SMBG) level
.Bolus insulin dose adjustment is not given a dose adjustment after administration as much as possible until 16 weeks.(16 weeks later, we allowed to regulate a dose based on administration algorithm)
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.Type 1 and Type 2 diabetes receiving Basal-bolus insulin therapy in outpatient
2.All subjects had been treated with basal-bolus insulin therapy for>4 months prior to trial acreening
3.In the case of type 1 diabetes, a duration of a disease is more than 12 months
4.The patients who are available for self monitoring of blood glucose
5.Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria
1.Patients with a history of hypersensitivity to insulin
2.Patients with severe ketosis, diabetic coma or the former comatose
3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis
4.Patients with the pre or proliferative retinopathy,including in the vitreous haemorrhage risk.
5.Patients with the serious infection, the perioperative period and the serious trauma
6.Patients with the pregnant woman or the woman who may be pregnant
7.In addition, the patient who judged inappropriate by an attendant physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyasu Fukui |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo,Japan
TEL
03-3784-8000
showauft@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyasu Fukui |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo,Japan
TEL
03-3784-8000
Homepage URL
showauft@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
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
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
| 2016 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 01 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024284
