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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020509
Receipt No. R000023674
Scientific Title Comparative Efficacy of Lixisenatide and Liraglutide on glucose variability and safety in CGM in Type 2 Diabetes with long-acting insulin
Date of disclosure of the study information 2016/01/08
Last modified on 2018/01/09

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Basic information
Public title Comparative Efficacy of Lixisenatide and Liraglutide on glucose variability and safety in CGM in Type 2 Diabetes with long-acting insulin

Acronym Comparative Efficacy of Lixisenatide and Liraglutide on glucose variability and safety in CGM in Type 2 Diabetes with long-acting insulin

Scientific Title Comparative Efficacy of Lixisenatide and Liraglutide on glucose variability and safety in CGM in Type 2 Diabetes with long-acting insulin

Scientific Title:Acronym Comparative Efficacy of Lixisenatide and Liraglutide on glucose variability and safety in CGM in Type 2 Diabetes with long-acting insulin

Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare lixisenatide with liraglutide on glucose variability and safety in type 2 diabetes patients with long-acting insulin by using continuous glucose monitoring (CGM).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MAGE(Mean amplitude of glycemic excursion)
of more than 10 days after thrapeutic intervention
Key secondary outcomes data in CGM (mean blood glucose, SD, pre-meal plasma glucose in point of care testing, M-value, hypoglycemic index), fasting plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose, lipid profile, blood pressure, heart rate, side effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lixisenatide
administration periods:more than 10 days
dose:15~20ug
the number of times:once a day before
breakfast
Interventions/Control_2 liraglutide
administration periods:more than 10 days
dose:0.6~0.9mg
the number of times: once a day before
breakfast
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients being in hospital for the purpose of intensive insulin therapy including long-acting insulin. (Fasting CPR>0.6ng/ml, total bolus insulin <15units/day)
Key exclusion criteria Patients with type 1 diabetes, patients with severe hypoglycemia, patients with severe liver disease, patients with severe renal disease, patients with severe heart disease, patients with history of myocardial infarction within 6 months, patients with severe pancreatic disease, cancer patients, patients with severe diabetic neuropathy, patients with severe diabetic retinopathy, patients with severe ketosis and in a coma, patients with history of digestive diseases, patients with history of gastrectomy, patients with lactose intolerance, heavy drinkers, patients using steroid, pregnant patients
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiko Imagawa
Organization University of Fukui
Division name Division of Endocrinology and Metabolism, Department of Internal medicine
Zip code
Address 23-3,Shimoaiduki, Matsuoka, Yoshidagun, Fukui,Japan
TEL 0776-61-3111
Email michikoi@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Imagawa
Organization University of Fukui
Division name Division of Endocrinology and Metabolism, Department of Internal medicine
Zip code
Address 23-3,Shimoaiduki, Matsuoka, Yoshidagun, Fukui,Japan
TEL 0776-61-3111
Homepage URL
Email michikoi@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Division of Endocrinology and Metabolism, Department of Internal medicine,
University of Fukui
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
Address
Tel
Email

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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 08 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023674

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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