UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020509 |
|---|---|
| Receipt number | 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 09:27:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
michikoi@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023674
