UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030648 |
|---|---|
| Receipt number | R000034993 |
| Scientific Title | Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy). |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/07/24 19:29:49 |
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Basic information
Public title
Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Acronym
Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Scientific Title
Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Scientific Title:Acronym
Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of time with in the predefined FGM glucose range of 70-179mg/dl(normal range).
Key secondary outcomes
Percentage of time with in the predefined FGM glucose range of >180mg/dl (hyperglycemia range) <70mg/dl(hypoglycemia range)
<54mg/dl(severe hypoglycemia range)
Nocturnal hypoglycemia(0:00-5:59)
mean glucose level,SD-value,CV-value,Mean Amplitude of Glycemic Excursions,M-value,MODD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Deguldec/Aspart is administered twice in the morning and evening, and the dosage is adjusted to fix the unit going to pre-breakfast and pre-dinner with the goal of 100-130mg/dl.
FGM (Flash Glucose Monitoring) is attached and the blood glucose level on the 2-4days is evaluated.
FGM (Flash Glucose Monitoring) is attached and the blood glucose level on the 2-4days is evaluated.
Switching 80% of basal dose of degludec/aspart to glarginU300 morning dose, switching same dose of bolus to glulisine evening,
2-h postprandial blood glucose adjust glulisine to target less than 180mg/dl blood glucose (5-6days).
Increase the basal amount of degludec/aspart at the time of switching glargine U300.
2-h postprandial blood glucose adjust glulisine to target less than 180 mg/dl blood glucose (7-12days)
Evaluate blood glucose level on 12-14days
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetic patients who are needed to glycemic contro
Key exclusion criteria
1.Serious ketosis, history of diabetic coma or precoma
2.Pregnancy or lactation and patients scheduled
3.Serious infection, trauma, undergo surgery
4.Receiving steroid therapy.
5.Severe liver dysfunction
6.Type 1 diabetes
7.Hypersensitivity to degludec/aspart, glargin, glulisine.
8.History of malignancy or malignancy.
9.Judged to be unsuitable for participation for medical reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kawaguchi |
Organization
Minami Osaka hospital
Division name
Internal medicine
Zip code
Address
1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan
TEL
06-6685-0221
y.kawaguchi@minamiosaka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Kawaguchi |
Organization
Minami Osaka hospital
Division name
Internal medicine
Zip code
Address
1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan
TEL
06-6685-0221
Homepage URL
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
南大阪病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
| 2017 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 30 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034993
