UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000006858
Receipt No. R000008099
Scientific Title Recearch for the role of the action of GLP-1 on normal glucose tolerance
Date of disclosure of the study information 2011/12/07
Last modified on 2019/12/10 (Ver. 5)

* 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 Recearch for the role of the action of GLP-1 on normal glucose tolerance
Acronym Recearch for the role of the action of GLP-1 on normal glucose tolerance
Scientific Title Recearch for the role of the action of GLP-1 on normal glucose tolerance
Scientific Title:Acronym Recearch for the role of the action of GLP-1 on normal glucose tolerance
Region
Japan

Condition
Condition Normal glucose tolerance
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of incretin related drugs for type 2 diabetes is widely noticed.Glucose dependent insulin secretion,glucose dependent glucagon suppression,inhibiton of gastrointestinal motility and protective effects for pancreatic B cell are well-known as the effects of incretin.However,on the human beings, it is not acceptable that how affect the many sided incretin action.Uncovering the incretin action on human is very important for determine that we should choice what kinds of incretin related drugs and use for what kinds of condition.
On the otherhand,the condition of type 2 diabetes is heterogeneity and it is not suitable for research of physiological incretin action,so we should evaluate the incretin effects in consideration of the ability of insulin secretion and insulin resistance.
Therefor,we research the role of incretin action on normal glucose tolerance that have relatively homogenous ability of insulin secretion and insulin resistance.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum blood glucose,insulin,CPR,gulucagon which are obtain from OGTT
Time:0,5,10,15,30,60,90,120,150,180 min
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 [exenatide]
subcutaneous injection of exenatide 5 ug, 30 min before 75gOGTT.
[liraglutide]
subcutaneous injection ofliraglutide 0.9 mg, 10hr before 75gOGTT.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Normal glucose torerance
Key exclusion criteria ad lib blood glucose >= 200 mg/dl
hypersensitivity for the drugs
pregnancy or the possibility
HbA1c >= 6.1%
severe renal dysfunction and liver function
Considering unsuitable for this research with other reasons

Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yushi
Middle name
Last name Hirota
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Enocrinology
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5861
Email hirota@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yushi
Middle name
Last name Hirota
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Enocrinology
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5861
Homepage URL
Email hirota@med.kobe-u.ac.jp

Sponsor
Institute Division of Diabetes and Enocrinology
Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Trust Acounts of medical office
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization kobe University kainyu Kenkyu
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel 078-382-6669
Email kainyu@med.kobe-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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 07 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007%2Fs12020-018-1808-9
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs12020-018-1808-9
Number of participants that the trial has enrolled 14
Results 
Exenatide, but not liraglutide, markedly decelerated the peak of both plasma glucose and serum insulin levels during the OGTT, with the peaks of both glucose and insulin concentrations occurring at 150？min after test initiation with exenatide compared with 30？min in the control condition or with liraglutide. Exenatide and liraglutide reduced the area under the curve for plasma glucose levels during the OGTT by similar extents, whereas that for serum insulin levels was reduced only by exenatide.
Results date posted
2019 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 11 Month 08 Day
Baseline Characteristics 
Normal glucose tolerance
Participant flow 
We recruited volunteers.
Adverse events 
None.
Outcome measures 
Differences between three OGTTs, which were performed without pharmacological intervention or after a single administration of exenatide or liraglutide at 30 min and 10 h, respectively, before test initiation.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
2013 Year 04 Month 30 Day
Date trial data considered complete
2013 Year 04 Month 30 Day
Date analysis concluded
2016 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 07 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008099