UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014417 |
|---|---|
| Receipt number | R000016773 |
| Scientific Title | Effects of Linagliptin on Hypoglycemia :Hypoglycemic Clamp Test in Japanese T2DM Patients |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2016/12/09 09:34:37 |
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Basic information
Public title
Effects of Linagliptin on Hypoglycemia
:Hypoglycemic Clamp Test in Japanese T2DM Patients
Acronym
Hypoglycemic Clamp Test in Japanese T2DM Patients
Scientific Title
Effects of Linagliptin on Hypoglycemia
:Hypoglycemic Clamp Test in Japanese T2DM Patients
Scientific Title:Acronym
Hypoglycemic Clamp Test in Japanese T2DM Patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To show that the glucagon secretion to hypoglycemia is significantly enhanced by biologically intact GIP elevated by linagliptin treatment.
Basic objectives2
Others
Basic objectives -Others
To explore the hormonal response (i.e. Epinephrine, Norepinephrine, Cortisol, GH) to hypo-glycemic condition before and after the linagliptin/liragltide treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2 weeks after Linagliptin/Liraglutide treatment:
(1)Changes in plasma levels of glucagon
(2)Its correlation with biologically intact GIP
Key secondary outcomes
To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2weeks after Linagliptin/Liraglutide treatment:
(1)ISR, ISR/Glucose
(2)Pancreatic and autonomic hormonal response to hypoglycemia(Epinephrine, Norepinephrine, Cortisol, GH)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitor(Linagliptin) group
Interventions/Control_2
GLP-1 receptor agonist(Liraglutide) group
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Japanese T2DM patients
(2)Patients treated with 1OAD or not treated with OAD
(3)HbA1c (NGSP) 6.0 - 8.0 at screening visit
(for patient treated with 1OAD)
6.0 - 8.5 (for patient not treated with OAD) at screening visit (regardless of sex)
(5)BMI<30kg/m2
Key exclusion criteria
(1)Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc)
(2)Patients currently treated with Insulin, DPP-4inhibitor, GLP-1 receptor agonist within 4 weeks and/or treated with Pioglitazon within 12weeks
(3)Patients currently treated with alpha blocker, beta blocker, selective serotonin reuptake inhibitors
(4)Patients with history of cerebrovascular and cardiovascular disease
(5)Patients with heart failure with NYHA I-IV
(6)Patients with renal dysfunction
(7)Patients with severe hepatic dysfunction
(8)Patients with history of pancreatitis
(9)Patients with diabetic retinopathy
(proliferative retinopathy, vitreous hemorrhage and more severe condition)
(10)Patients with autonomic neuropathy
(11)Patients with a history of surgery of gastrointestinal tract
(12)Patients with malignant tumor
(13)Patients with severe infection, in the perioperative period or with serious injury
(14)Excessive alcohol intake
(15)Patients with hemoglobin (Hb) <13.0g/dL(male), <12.5g/dL(female)
(16)Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator
(17)Patients participating in other clinical studies
(18)Pregnant or possibly pregnant women
(19)Patients judged as inadequate to participate in present study by investigator or sub-investigator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
ydaisuke-kyoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
Homepage URL
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical Co. LTA HAKATA CLINIC
Name of secondary funder(s)
Eli Lilly & Co.
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
医療法人相生会 博多クリニック（福岡県）/Medical Co.LTA HAKATA CLINIC (Fukuoka)
関西電力病院（大阪府）/ Kansai Electric Power Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/dom.12817/full
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 29 | Day |
Last modified on
| 2016 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016773
