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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030648
Receipt No. 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

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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
Email 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
Email y.kawaguchi@minamiosaka.com

Sponsor
Institute Minami Osaka hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034993

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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