UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000005565
Receipt number	R000006226
Scientific Title	Combination therapy for diabetic subjects with insulin and liraglutide
Date of disclosure of the study information	2011/05/06
Last modified on	2020/06/04 12:49:54

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Basic information

Public title

Combination therapy for diabetic subjects with insulin and liraglutide

Acronym

insulin and liraglutide for diabetics

Scientific Title

Combination therapy for diabetic subjects with insulin and liraglutide

Scientific Title:Acronym

insulin and liraglutide for glycemic control and cardiac function

Region

Japan

Condition

diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

to evaluate the cardiac function on UCG and glycemic control on liraglutide introduction

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Assessment

Primary outcomes

cardiac function on UCG 6 months after the liraglutide introduction

Key secondary outcomes

HbA1c, fasting blood glucose, fasting plasma CPR, urinary CPR, fasting glucagon, T-cho, TG, LDL-C, small dense LDL, pre-beta1HDL

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

treat the subjects with maximum dose of 0.9mg per day of liraglutide

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

30 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) type 2 diabetes, aged >30 years old, and treated with insulin for more than five years; 2) no use of incretin-based therapy at baseline; 3) tolerable to daily injection of liraglutide; 4) preserved left ventricular ejection fraction (LVEF greater than equal to 40%); 5) no symptomatic heart failure; 6) no history of heart failure admission; 7) no coronary intervention within three years; and 8) no critical primary heart disease, including ventricular arrhythmias, persistent atrial fibrillation, complete atrioventricular block, cardiomyopathy, and valvular disease.

Key exclusion criteria

1) endocrine disorders, including type-1 diabetes; 2) refractory malignant tumors; 3) dependency on hemodialysis; and 4) severe hepatic dysfunction (Child-Pugh score greater than equal to 10).

Target sample size

Research contact person

Name of lead principal investigator

1st name Kunimasa

Middle name

Last name Yagi

Organization

Kanazawa University Hospital

Division name

department of endocrinology and metabolism

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa

TEL

+81-76-265-2264

Email

diabe@med.kanazawa-u.ac.jp

Public contact

Name of contact person

1st name Kunimasa

Middle name

Last name Yagi

Organization

Kanazawa University Hospital

Division name

department of endocrinology and metabolism

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa

TEL

+81-76-265-2264

Homepage URL

Email

diabe@med.kanazawa-u.ac.jp

Sponsor or person

Institute

Kanazawa University, Graduate School of Internal Medicine, department of internal medicine

Institute

Department

Personal name

Funding Source

Organization

Kanazawa University, Graduate School of Internal Medicine, department of internal medicine

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

Kanazawa Univeristy

Address

13-1 Takaramachi, Kanazawa 920-8641

Tel

076-265-2000

Email

diabe@med.kanazawa-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 06 Day

Related information

URL releasing protocol

http://intmed2.w3.kanazawa-u.ac.jp

Publication of results

Published

Result

URL related to results and publications

http://intmed2.w3.kanazawa-u.ac.jp

Number of participants that the trial has enrolled

Results

BNP and E/E' improved, with BNP levels declining from 36.8+-30.5pg/ml to 26.3+-25.9pg/ml (p=0.0014) and E/E' dropping from 12.7+-4.7 to 11.0+-3.3(p=0.0376).
E/E' improved only in patients with E/E' greater than and equal to 13.0. Favorable changes in E/E' were canceled when adjusted for body mass index (BMI).
Multivariate linear regression analyses revealed that left ventricular diastolic diameter and deltaE/E'/deltaBMI contributed to deltaBNP/baseline BNP (p=0.0075, R2=0.49264).

Results date posted

2020 Year 05 Month 12 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The inclusion criteria were as follows: 1) type 2 diabetes, aged over 30 years old, and treated with insulin for more than five years; 2) no use of incretin-based therapy at baseline; 3) tolerable to daily injection of liraglutide; 4) preserved left ventricular ejection fraction (LVEF over and equal to 40%); 5) no symptomatic heart failure; 6) no history of heart failure admission; 7) no coronary intervention within three years; and 8) no critical primary heart disease, including ventricular arrhythmias, persistent atrial fibrillation, complete atrioventricular block, cardiomyopathy, and valvular disease. The diagnoses of type 2 diabetes were based on the ADA diagnostic criteria.
The exclusion criteria were as follows: 1) endocrine disorders, including type-1 diabetes; 2) refractory malignant tumors; 3) dependency on hemodialysis; and 4) severe hepatic dysfunction (Child-Pugh score over and equal to 10).

Participant flow

All the patients were administered liraglutide injections at the maximum dose of 0.9 mg per day following the protocol provided by Novo Nordisk Japan (the maximal liraglutide dosage permitted was 0.9 mg in Japan during the study period). The diabetologists adjusted the participants' insulin doses to achieve fair HbA1c levels less than 7.0% and to avoid hypoglycemia (i.e., plasma glucose levels below 70 mg/dl). The pharmacists educated the participants on the use of liraglutide during the admission period. All patients continued their daily liraglutide injections throughout the study period. The patients' records ensured adherence and persistence.

Adverse events

nothing

Outcome measures

The primary outcome was the changes in serum BNP levels and the secondary outcomes were the TTE parameters, blood pressure, bodyweight, and laboratory data following liraglutide treatment for 26 weeks.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 11 Month 01 Day

Date of IRB

2011 Year 03 Month 31 Day

Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2014 Year 06 Month 02 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2011 Year 05 Month 06 Day

Last modified on

2020 Year 06 Month 04 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006226

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name