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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037941
Receipt No. R000043247
Scientific Title Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/05

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Basic information
Public title Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Acronym Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Scientific Title Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Scientific Title:Acronym Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec 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 To evaluate the relationship between serum albumin levels and free fatty acids in patients with type 2 diabetes undergoing Basal Supported Oral Therapy (BOT) with insulin glargine 300 U/mL (Gla300) and insulin degludec (Deg).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between blood glucose level, serum albumin level and free fatty acid in BOT
Key secondary outcomes Time range of blood glucose level less than 70mg/dl (hypoglycemic range), blood glucose level 180mg/dl or higher (hyperglycemic range), blood glucose level 70-179mg/dl (normal range), blood glucose level less than 54 mg/dl (severe hypoglycemia range), nocturnal hypoglycemia (0: 00-5: 59, less than 70 mg / dl) in 3 days FGM, severe hypoglycemia (diabetic coma or pre-coma, convulsions requiring third-party assistance), mean blood glucose level, standard deviation value, coefficient of variation value, daily fluctuation, M value, mean amplitude of glycemic excursions, changes in the dose of insulin

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 Gla300-Deg
Interventions/Control_2 Deg-Gla300
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 the start of the study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding Gla300 and Deg) for more than 6 months before screening
2. Patients of glycated hemoglobin (HbA1c) levels 7.0% or more and less than 11.0%
Key exclusion criteria 1. Patients with a history of severe ketosis, diabetic coma or precoma within 6 weeks
2. Patients who developed severe hypoglycemia (diabetic coma or precoma, convulsions requiring third party assistance) within 6 weeks
3. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level above 2.0mg/dL) or endstage renal failure patients 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 severe gastrointestinal tract surgery
6. Pregnant women or women who may be pregnant and breastfeeding patients
7. Patients with severe infections, before and after surgery, and severe trauma
8. Patients receiving systemic corticosteroids
9. Patients with severe liver dysfunction (AST or ALT higher than 100U/l)
10. Patients with a history of allergies to the drug to be used for research
11. Patients with malignant tumor or history of malignant tumor
12. Other patients judged by the investigator as inappropriate as subjects
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Yasuro
Middle name
Last name Kumeda
Organization Minami Osaka Hospital
Division name Internal medicine
Zip code 559-0012
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 559-0012
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
2019 Year 10 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 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
2019 Year 09 Month 05 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043247

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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