UMIN-CTR Clinical Trial

Public title

Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)

Acronym

Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)

Scientific Title

Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)

Scientific Title:Acronym

Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)

Region

Japan

Condition

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The present study was designed for the following purpose. First, to compare the blood glucose fluctuations and the levels of various hormones from midnight to early morning between the group of patients administered Glargine and the group administered Glargine XR, in order to achieve higher-quality blood glucose control. Second, to measure blood glucose level and the levels of various hormones including insulin-antagonistic hormones from midnight to early morning to clarify the association between changes in hormone levels and blood glucose fluctuations, thereby further characterizing the pathology of dawn phenomenon.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mean blood glucose and standard deviation of Flash Glucose Monitoring and Average and standard deviation of blood glucose levels and at 3:00 am and 7:00 am.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Glargine XR

Interventions/Control_2

Glargine

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with type 1 and type 2 diabetes who have agreed to the purpose and content of this study and have voluntarily agreed to the document.

Key exclusion criteria

Patients with adrenal and pituitary diseases, patients who are chronically administered steroids, patients with cancer and patients with gestational diabetes.

Target sample size

50

Name of lead principal investigator

1st name	shinobu
Middle name
Last name	sato

Organization

Chigasaki Municipal Hospital

Division name

Metabolism internal secretion internal medicine

Zip code

253-0042

Address

5-15-1, Honson, Chigasaki-shi, Kanagawa

TEL

0467-52-1111

Email

shinobu@medical.email.ne.jp

Name of contact person

1st name	masanori
Middle name
Last name	hasebe

Organization

Chigasaki Municipal Hospital

Division name

Metabolism internal secretion internal medicine

Zip code

253-0042

Address

5-15-1, Honson, Chigasaki-shi, Kanagawa

TEL

0467-52-1111

Homepage URL

Email

t186059g@yokohama-cu.ac.jp

Institute

Chigasaki Municipal Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chigasaki Municipal Hospital

Address

5-15-1, Honson, Chigasaki, Kanagawa

Tel

0467-52-1111

Email

hosp_soumu@city.chigasaki.kanagawa.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

09

Month

13

Day

URL releasing protocol

https://www.jstage.jst.go.jp/article/endocrj/70/8/70_EJ22-0562/_article

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/endocrj/70/8/70_EJ22-0562/_article

Number of participants that the trial has enrolled

47

Results

The mean blood glucose was significantly lower in the BS group, although the fluctuation was similar. The BS group also exhibited significantly higher delta ACTH and delta cortisol than the XR group. In the BS group, delta Glu exhibited a significant negative correlation with delta ACTH and delta cortisol. Further, analysis of the dawn phenomenon and non-dawn phenomenon groups showed the mean CPR levels at 3:00 and 7:00 were significantly higher in the latter.

Results date posted

2023

Year

11

Month

07

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Of the 43 patients whose patient information was collected and analyzed, 20 were assigned to the BS group and 23 to the XR group. Clinical and biochemical backgrounds were c similar at baseline. Mean age was 62.4 years in the BS group and 67.0 years in the XR group, and mean HbA1c was 10.8% in the BS group, 10.5% in the XR group. Two patients in the BS group were diagnosed with type 1 diabetes, but none in the XR group. Also, The mean eGFR was 80.8mL/min/1.73 m2 in the BS group and 80.1mL/min/1.73 m2 in the XR group, there was no statistical difference.

Participant flow

This study involved patients aged 20 years or older who had already been diagnosed with type 1 and type 2 diabetes and who were scheduled to be hospitalized for 2 weeks in the Department of Metabolism and Endocrinology and at Chigasaki City Hospital. Patients who consented to the purpose and content of the study and voluntarily gave written consent, were included.After admission to the hospital, subjects were first given intensive insulin therapy with the main purpose of eliminating glucotoxicity. After confirming the resolution of glucotoxicity, continuous blood glucose measurements were conducted.After wearing the Abbott FreeStyle Libre Pro device, the assigned long-acting insulin was administered, and blood glucose changes were monitored using isCGM (intermittently scanned continuous glucose monitoring) from 0:00 a.m. until 7:00 a.m.. Blood samples were also collected at 3:00 a.m. and 7:00 a.m. to measure blood glucose levels, C-peptide, growth hormone, cortisol, ACTH, catecholamines, and glucagon.

Adverse events

No significant adverse events associated with the clinical study were observed.

Outcome measures

The primary endpoints were mean value and standard deviation of intermittently scanned continuous glucose monitoring (isCGM) and blood glucose (Glu) levels at 3:00 and 7:00. The secondary endpoints were GH, cortisol, ACTH, catecholamines, and glucagon levels at 3:00 and 7:00.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

16

Day

Date of IRB

2018

Year

02

Month

16

Day

Anticipated trial start date

2018

Year

07

Month

31

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

13

Day

Last modified on

2023

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051529