UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039460
Receipt number R000044993
Scientific Title Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes
Date of disclosure of the study information 2020/02/11
Last modified on 2023/05/10 13:05:37

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Basic information

Public title

Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes

Acronym

Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes

Scientific Title

Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes

Scientific Title:Acronym

Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effects of switching from DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on glucose fluctuation in patients with type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of mean amplitude of glycemic excursions (MAGE) before and after switching of treatment

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with type 2 diabetes who were hospitalized in Hokkaido University Hospital from February 2020 to December 2021.
2) 20-80 years old
3) HbA1c >= 6.5%
4) Patients who have been treated with combination therapy using DPP-4 inhibitor and insulin degludec (<=16 unit/day) for more than 3 days with stable blood glucose condition
5) Treatment with degludec/liraglutide will be appropriate to achieve preferable glycemic control
6) Agreement to participate to this study

Key exclusion criteria

1) History of anaphylaxis of insulin degludec or liraglutide
2) Unstable glycemic control
3) Severe hepatic dysfunction, renal dysfunction
4) Pregnancy
5) Diabetic ketosis, coma and precoma
6) Serious infection, pre-or post-surgery
7) Poor adherence to dietary therapy
8) Poor insulin secretion
9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Nomoto

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code

060-0811

Address

North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

hnomoto@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Nomoto

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code

060-0811

Address

North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL


Email

hnomoto@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



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

Hokkaido University Hospital Clinical Research Management Department

Address

North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan

Tel

011-706-7636

Email

crjimu@med.hokudai.ac.jp


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

北海道大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 11 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35097130/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35097130/

Number of participants that the trial has enrolled

15

Results

Switching from DPP-4 inhibitor plus insulin degludec to IDegLira significantly improved MAGE from 74.9 (60.3, 97.7) mg/dL to 64.8 (52.0, 78.2) mg/dL (P < 0.05), as well as other indices of GV and 24-hour mean blood glucose concentration.

Results date posted

2023 Year 05 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We recruited hospitalized patients with type 2 diabetes who had stable glycemic control with insulin degludec (within 16 units/day) and taking a DPP-4 inhibitor.

Participant flow

We recruited the patents who met the inclusion criteria and agreed to participate to this study.

Adverse events

None

Outcome measures

Refer to the section of "2.3. Continuous Glucose Monitoring" in the main paper.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 02 Month 07 Day

Date of IRB

2020 Year 02 Month 07 Day

Anticipated trial start date

2020 Year 02 Month 10 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

Other related information

None


Management information

Registered date

2020 Year 02 Month 11 Day

Last modified on

2023 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044993


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name