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Recruitment status
Unique ID issued by UMIN UMIN000022661
Receipt No. R000026087
Scientific Title The influence of sulfonylurea or dipeptidyl-peptidase-4 inhibitor on glucose control and the secretion of glucagon and insulin induced by sodium glucose transporter-2 inhibitor in type2 diabetic patients
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/08

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Basic information
Public title The influence of sulfonylurea or dipeptidyl-peptidase-4 inhibitor on glucose control and the secretion of glucagon and insulin induced by sodium glucose transporter-2 inhibitor in type2 diabetic patients
Acronym The influence of sulfonylurea or dipeptidyl-peptidase-4 inhibitor on the secretion of glucagon and insulin induced by sodium glucose transporter-2 inhibitor

Scientific Title The influence of sulfonylurea or dipeptidyl-peptidase-4 inhibitor on glucose control and the secretion of glucagon and insulin induced by sodium glucose transporter-2 inhibitor in type2 diabetic patients
Scientific Title:Acronym The influence of sulfonylurea or dipeptidyl-peptidase-4 inhibitor on the secretion of glucagon and insulin induced by sodium glucose transporter-2 inhibitor

Region
Japan

Condition
Condition Type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To examine the effect of sodium glucose transporter-2 inhibitor(SGLT2i) on glucagon and insulin secretion and insulin sensitivity in type2 DM patients.
2. To examine the effect of addition of low dose sulfonylurea (SU) or dipeptidyl-peptidase-4 inhibitor (DPP-4i) to SGLT2i on glucagon secretion.
3. To compare the effect of sulfonylurea (SU) and dipeptidyl-peptidase-4 inhibitor (DPP-4i) added on SGLT2i on glucose control and the secretion of glucagon and insulin in type2 diabetic patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The alternations in glucose and insulin responses after the intravenous glucose load, HbA1c level and fasting glucagon concentration 3 months after administration of SGLT2i and then 3 months after addition of SU or DPP-4i to SGLT2i.

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 SGLT2i, dapagliflozin 5mg, is administrated once a daily after breakfast during 6-months
Interventions/Control_2 3-months after the start of SGLT2i, low dose sulfonylurea, glimeprid 0.5mg, or DPP-4i, linagliptin 5mg, is added on SGLT2i during 3-months.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Type2 DM who have been treated on life-style intervension alone and on life-style intervension plus metformin and whose HbA1c have not been controlled under 7.5%
Key exclusion criteria 1. Malignancy
2. Renal dysfunction(eGFR<60ml/min)
3. Liver dysfunction(AST>100U/l and/or ALT100>100U/l), except of fatty liver or non-alcoholic steatohepatitis
4. Pregnancy
5. Lactation
6. History of treatment for ischemic heart disease or other severe cardiovascular disease
7. Administration of any drugs affecting plasma glucose concentration
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuya Horie
Organization Chiba Central Medical Center
Division name Diabetes Center
Zip code
Address 1835-1 Kasori Wakaba-ku Chiba city Chiba Pref. 264-0017
TEL 043-232-3691
Email horie@ccmc.seikei-kai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuya Horie
Organization Chiba Central Medical Center
Division name Diabetes Center
Zip code
Address 1835-1 Kasori Wakaba-ku Chiba city Chiba Pref. 264-0017
TEL 043-232-3691
Homepage URL
Email horie@ccmc.seikei-kai.or.jp

Sponsor
Institute Chiba Central Medical Center, Diabetes Center
Institute
Department

Funding Source
Organization self-sustaining
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
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 千葉中央メディカルセンター

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
Date of protocol fixation
2016 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026087

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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