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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014417
Receipt No. 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

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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
Email 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
Email ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016773

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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