UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021693 |
|---|---|
| Receipt number | R000025024 |
| Scientific Title | Efficacy of switching to Basal-supported GLP-1RA therapy(BGT) in type 2 diabetes patients treated with multiple daily insulin injections |
| Date of disclosure of the study information | 2016/03/30 |
| Last modified on | 2018/10/08 20:13:19 |
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Basic information
Public title
Efficacy of switching to Basal-supported GLP-1RA therapy(BGT) in type 2 diabetes patients treated with multiple daily insulin injections
Acronym
Efficacy of BGT in type 2 diabetes
Scientific Title
Efficacy of switching to Basal-supported GLP-1RA therapy(BGT) in type 2 diabetes patients treated with multiple daily insulin injections
Scientific Title:Acronym
Efficacy of BGT in type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the marker in the efficacy of switching to BGT in type 2 diabetes treated with multiple daily insulin injections
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We judge the case that the period when HbA1c < 7.0% was able to maintain it came across more than six months with a BGT effective case.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A type 2 diabetes patient treated with multiple daily insulin injections, whose HbA1c level > 8.0%.
Key exclusion criteria
Type 1 diabetes;
Suspicios for type 1 diabetes because of positiveness of GAD, IA-2 or ZnT8 antibodies in their sera;
Serum C-peptide level < 0.6 ng/ml;
Other type diabetes(Seconday diabetes, Steroid induced diabetes, ect.);
Pregnant women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Horie |
Organization
Nagasaki Univ. Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
holy197741@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Horie |
Organization
Nagasaki Univ. Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
Homepage URL
holy197741@me.com
Sponsor or person
Institute
First Dep. of Internal Medicine, Nagasaki Univ. Hospital
Institute
Department
Personal name
Funding Source
Organization
First Dep. of Internal Medicine, Nagasaki Univ. Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.diabres.2018.08.015
Number of participants that the trial has enrolled
Results
Results: Twenty-eight patients (68.3%) were identified as good-responders. No differences
were found in baseline characteristics including insulin/glucagon responses during 1st-
OGTT between the groups. 2nd-OGTT revealed that paradoxical hyperglucagonemia were
significantly improved in both groups, but significant increases in insulin secretory
response were observed only in good-responders. Logistic regression analyses revealed that
the improvement of the insulin-response during 2nd-OGTT compared to that during 1st-
OGTT is associated with the good-responder.Conclusions: Enhancement of glucose-dependent insulin-response under liraglutide administration
is a potential predictor of long-term glycaemic control after switching the
therapies.
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
The complete data is published on the journal of Diabetes Res Clin Pract as the title of "Predictive factors of efficacy of combination therapy with basal insulin and liraglutide in type 2 diabetes when switched from longstanding basal-bolus insulin: Association between the responses of beta- and alpha-cells to GLP-1 stimulation and the glycaemic control at 6？months after switching therapy".
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025024
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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