UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022661 |
|---|---|
| Receipt number | 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 | 2023/06/14 13:10:45 |
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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
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
horie@ccmc.seikei-kai.or.jp
Sponsor or person
Institute
Chiba Central Medical Center, Diabetes Center
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
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
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026087
