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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039221
Receipt No. R000044721
Scientific Title Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Date of disclosure of the study information 2020/02/10
Last modified on 2020/03/10

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Basic information
Public title Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Acronym Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Scientific Title Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Scientific Title:Acronym Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the difference in glycemic control by treating patients with type 2 diabetes who need hospitalization for glycemic control with insulin degludec/insulin aspart (IDegAsp) and insulin degludec/liraglutide (IDegLira) .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of time of 3-day blood glucose 70-180 mg/dl (within target range), blood glucose 60 minutes, 90 minutes, and 120 minutes after each meal by using Flash Glucose Monitoring (FGM) for each treatment.
Key secondary outcomes Percentage of time of 3-day blood glucose level less than 70 mg/dl (below target range), blood glucose level above 180 mg/dl (above target range), blood glucose level less than 54 mg/dl (severe hypoglycemic range), blood glucose level less than 70 mg/dl during night (0:00-6:00), The frequency of severe hypoglycemia (requiring the assistance of a third person, such as diabetic coma or precoma, convulsions), average blood glucose level, standard deviation value, coefficient of variation value, day to day variation, M-value, mean amplitude of glycemic excursions, C-peptide index pre and post-treatment, fasting blood glucose in early morning, Insulin degludec dose in each insulin-containing injection

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Switching IDegLira after IDegAsp prior treatment
Interventions/Control_2 Switching IDegAsp after IDegLira prior treatment
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 have been diagnosed with type 2 diabetes for more than 1 year before this study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding IDegAsp and IDegLira) for at least 6 months before screening.
2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%.
Key exclusion criteria 1.Patients with a history of severe ketosis, diabetic coma or previous coma within 6 weeks of this study.
2.Patients with a history of severe hypoglycemia (diabetic coma or pre-coma and convulsions needing third person assistance) within 6 weeks of this study.
3.Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine 2.0mg/dL and more) or end-stage renal failure on dialysis.
4.Patients with proliferative retinopathy (however, patients who have undergone photocoagulation and have stable symptoms can be included).
5.Patients with a history of surgery for severe gastrointestinal disease.
6.Pregnant or possibly pregnant and lactating patients.
7.Patients with severe infections, before and after surgery, with severe trauma.
8.Patients receiving systemic corticosteroids.
9.Patients with severe liver dysfunction (high AST or ALT 100 U/L and more).
10.Patients with a history of allergy to the drug to be used in this study.
11.Patients with malignancy or a history of malignancy.
12.Patients judged by the investigator to be inappropriate as subjects.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Kawaguchi
Organization Minami Osaka Hospital
Division name Internal medicine
Zip code 5590012
Address 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL 0666850221
Email y.kawaguchi@minamiosaka.com

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Kawaguchi
Organization Minami Osaka Hospital
Division name Internal medicine
Zip code 5590012
Address 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL 0666850221
Homepage URL
Email y.kawaguchi@minamiosaka.com

Sponsor
Institute Minami Osaka Hospital
Institute
Department

Funding Source
Organization Minami Osaka Hospital
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 Minami Osaka Hospital
Address 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
Tel 0666850221
Email y.kawaguchi@minamiosaka.com

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
2020 Year 02 Month 10 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 21 Day
Date of IRB
2020 Year 02 Month 04 Day
Anticipated trial start date
2020 Year 02 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 21 Day
Last modified on
2020 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044721

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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