UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015033
Receipt number R000017489
Scientific Title Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
Date of disclosure of the study information 2014/09/03
Last modified on 2017/09/04 14:27:21

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Basic information

Public title

Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-

Acronym

Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM

Scientific Title

Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-

Scientific Title:Acronym

Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of DPP-4 Inhibitors and Dapagliflozin using CGM in patients with type 2 diabetes treating with insulin

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

Mean Amplitude of glycemic excursions: MAGE

Key secondary outcomes

1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sitagliptin
Vildagliptin
Teneligliptin
Linagliptin
Alogliptin
Saxagliptin

Interventions/Control_2

Dapagliflozin

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) patients with type 2 diabetes treating in combination with Inslin and DPP-4 inhibitors 2) HbA1c 6.0-9.0% 3) written informed consent

Key exclusion criteria

1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code


Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

hidemiyoshi2003@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code


Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL


Email

hidemiyoshi2003@yahoo.co.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-017-0255-8

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 08 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 07 Day

Last follow-up date

2017 Year 02 Month 28 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 09 Month 02 Day

Last modified on

2017 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017489


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name