UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031070
Receipt number R000035484
Scientific Title Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols
Date of disclosure of the study information 2018/01/31
Last modified on 2020/03/31 12:07:41

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Basic information

Public title

Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols

Acronym

Randomized prospective study for perioperative diabetes control within enhanced recovery after surgery (ERAS) protocols

Scientific Title

Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols

Scientific Title:Acronym

Randomized prospective study for perioperative diabetes control within enhanced recovery after surgery (ERAS) protocols

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of liraglutide, a GLP-1RAg, for perioperative glycemic control in type 2 diabetes patients undergoing elective surgery with ERAS protocols in a randomized prospective study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

blood glucose fluctuation

Key secondary outcomes

insulin dosage and days prescribed for the correction of elevated blood glucose levels, frequency of hypoglycemic events, tolerance,changes in lean body mass, changes in body fat and visceral fat area


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

perioperative periods, liraglutide 0.9mg

Interventions/Control_2

insulin therapy

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Adults (age 20 and above) with type 2 diabetes25 who received at least 3 months of previous antidiabetic treatment, had values of BMI over 20 kg/m2 inclusive with HbA1c 6.0% and above who were scheduled to undergo elective surgery within ERAS protocols were eligible

Key exclusion criteria

Patients who were to undergo gastrointestinal or neurosurgical procedures were excluded. Patients who tested positive for anti-GAD (glutamate decarboxylase) antibodies or with elevated ALT (2 times upper normal range) were excluded from the study. Patients with autonomic neuropathy or recurrent severe hypoglycemia were also excluded.
Patients who had been administered any drug except for oral antidiabetic drugs (OADs), which could interfere with glucose level or bodyweight (i.e. systemic corticosteroids, orlistat or sibutramine), were also excluded. Patients who had been administered sGLT-2 inhibitor or thiazolidinediones were excluded because these medicines could interfere with accurate bodyweight changes

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shizuka
Middle name
Last name Kaneko

Organization

Takatsuki Redcross Hospital

Division name

Diabetes, endocrinology and life-related disease

Zip code

569-1096

Address

1-1-1 Abuno Takatsuki Osaka, Japan

TEL

072-696-0571

Email

skayamoe@takatsuki.jrc.or.jp


Public contact

Name of contact person

1st name Kaneko
Middle name
Last name Shizuka

Organization

Takatsuki Redcross Hospital

Division name

Diabetes, endocrinology and life-related disease

Zip code

569-1096

Address

1-1-1 Abuno Takatsuki Osaka, Japan

TEL

072-696-0571

Homepage URL


Email

skayamoe@takatsuki.jrc.or.jp


Sponsor or person

Institute

Takatsuki redcross hospital

Institute

Department

Personal name



Funding Source

Organization

JAPAN VASCULAR DISEASE RESEARCH FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Takatsuki Red Cross Hospital

Address

1-1-1 Abuno Takatsuki,Osaka

Tel

0726960571

Email

kensyu@takatsuki.jrc.or.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

日本赤十字社 高槻赤十字病院


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 31 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/30537714

Publication of results

Unpublished


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/30537714

Number of participants that the trial has enrolled

100

Results

Liraglutide was shown to be a more effective option than insulin therapy because (1) glycemic levels were more stable; (2) the number of patients requiring additional insulin according to the insulin sliding scale was significantly smaller (p = 0.005); (3) the insulin dosage required on the day of surgery was significantly smaller (p = 0.004); (4) the additional insulin volume required was significantly less for patients throughout the perioperative period (p = 0.001).

Results date posted

2019 Year 08 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Forty nine subjects (male 24, age 67.2 +/- 10.2 years, disease duration 10.1 +/- 9.4 years, HbA1c 7.12 +/- 0.96%) were prescribed liraglutide, and 41 (male 14, age 70.9 +/- 8.5 years, disease duration 14.6 +/- 10.2 years, HbA1c 7.78 +/- 1.23%) were administered insulin therapy before elective surgeries (Fig. 2). Surgeries comprised orthopedic (34 vs. 35 cases), thoracic(6 vs. 4 cases), and urological (5 vs. 1 cases) procedures for patients receiving liraglutide orinsulin therapy, respectively (Table 1). Subjects undergoing otolaryngological (n = 2), hepatic resection (n = 1), and gynecological (n = 1) surgeries were administered liraglutide, while
those undergoing breast surgery (n = 1) were administered insulin therapy (Table 1). General anesthesia (with/without epidural anesthesia, infiltration anesthesia, or a nerveblock) was administered to 46 subjects (93.9%) with liraglutide therapy and 38 (92.7%) with insulin therapy, respectively, and spinal or epidural anesthesia to the remaining 3 (6.1%) and 2 subjects, respectively (7.3%).

Participant flow

Three out of 100 eligible subjects who were screened were excluded because they did not meet the inclusion criteria. Informed consent was obtained from 97 adult T2D patients who were scheduled to undergo elective surgery within ERAS protocols. Ninety-seven individuals
were randomized. Seven subjects were subsequently excluded from the present study for the following reasons, 1 patient who was allocated to the insulin treatment group retracted his/her agreement. Two patients withdrew from insulin therapy because blood glucose levels decreased, and there was an increase in the risk of hypoglycemia due to the continuation of insulin therapy. Patients elected to discontinue insulin therapy, 1 patient was moved to another hospital for surgery and withdrew, and 1 withdrew because of an inability to consume food due to vomiting and nausea associated with anesthesia after surgery. Insulin therapy was stopped. Two patients did not undergo orthopedic surgery due to symptom improvements as a result of decreases in their body weights. Therefore, 90 subjects were ultimately
analyzed.

Adverse events

Hypoglycemic events were observed in none of the liraglutide group and in 5 subjects
(12.2%) in the insulin group. Gastrointestinal adverse events, typified by mild and tolerable nausea, were observed in 3 (6.1%) subjects in the liraglutide group and in none of the insulin group. Delayed wound healing, infection, or other complications were not observed in patients receiving either of the therapies.

Outcome measures

Glycemic fluctuations, hypoglycemic events, the number of days and insulin, dosages prescribed according to insulin sliding therapy, and perioperative complications were analyzed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 01 Month 15 Day

Date of IRB

2015 Year 09 Month 01 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2016 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 10 Month 23 Day

Date trial data considered complete

2018 Year 10 Month 23 Day

Date analysis concluded

2018 Year 10 Month 23 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 31 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035484


Research Plan
Registered date File name
2019/08/11 臨床応用実施申請書eRAS Dual ScanH27,28                .pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/08/12 【周術期ERAS強化】解析結果20171007UMIN登録.xlsx