UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030043
Receipt number R000033260
Scientific Title Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor
Date of disclosure of the study information 2018/02/06
Last modified on 2019/01/28 13:00:51

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Basic information

Public title

Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor

Acronym

Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor

Scientific Title

Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor

Scientific Title:Acronym

Examination of the glucose metabolism improvement effects by the combination of DPP-4 inhibitor and SGLT2 inhibitor

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the clinical effects and the underlying mechanisms of novel anti-diabetic combination drug (teneligliptin + canagliflozin).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic control assessed by meal tolerance test and continuous glucose monitoring on each treatment period

Key secondary outcomes

1) Insulin secretion capacity and pattern
2) Incretin (GLP-1, GIP) secretion capacity and pattern
3) Glucagon secretion capacity and pattern
4) Ghrelin secretion capacity and pattern
5) Des-acyl ghrelin secretion capacity and pattern
6) C peptide secretion capacity and pattern
7) Changes in urine volume, urinary C peptide, urinary protein, and urinary glucose
8) Changes in body weight, body composition, blood pressure, and pulse rate
9) Changes in renal function, liver function, uric acid, serum lipid, keton body, HOMA-R, and HOMA-beta


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Under hospitalized for 2 weeks, patients will be orally administered Tenellia 20 mg/day from day 4 to day 10. Then, patients will be taken Canalia 1 tablet/day from day 11 to day 14.

Interventions/Control_2


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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients aged 20 to 75 years old with type 2 diabetes. HbA1c: 7~10% with no medication or only metformin.

Key exclusion criteria

1. Patient who cannnot regulary visit hospital
2. Patient with advanced diabetic retinopathy
3. Dialysis patient with diabetes
4. Patient who judged inappropriate due to the complications and treatment by attending doctor

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Ueno

Organization

University of Miyazaki , fuculty of medicine

Division name

Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan

TEL

0985-85-2965

Email

intron@med.miyazaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ueno

Organization

University of Miyazaki , fuculty of medicine

Division name

Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine

Zip code


Address

5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan

TEL

0985-85-2965

Homepage URL


Email

intron@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki , fuculty of medicine, Endocrinology, Metabolism and Diabetes Mellitus, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Tanabe Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

宮崎大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 06 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

Completed

Date of protocol fixation

2018 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 28 Day

Last follow-up date

2019 Year 03 Month 29 Day

Date of closure to data entry

2019 Year 03 Month 29 Day

Date trial data considered complete

2019 Year 03 Month 29 Day

Date analysis concluded

2019 Year 03 Month 29 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 20 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name