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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005565
Receipt No. 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

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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
Condition diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

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 1
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 32

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

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
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
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 31
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
URL(English) https://upload.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


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