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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name