UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037941
Receipt number 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 15:58:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Minami Osaka Hospital

Institute

Department

Personal name



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

Value
https://center6.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