UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014963
Receipt number R000017411
Scientific Title Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes
Date of disclosure of the study information 2014/08/30
Last modified on 2021/03/02 11:53:36

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Basic information

Public title

Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes

Acronym

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Scientific Title

Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes

Scientific Title:Acronym

COLOR stduy

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of ipraglifrozine and high-dose metformine in patients with type 2 diabetes under the treatment of low-dose metformine.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

The amount of change in HbA1c before and after the study

Key secondary outcomes

safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

increase the dose of metformine from 750 mg/day to 1500 mg/day and observe for 52 weeks

Interventions/Control_2

add 50 mg of ipraglyfrozine on 750 mg/day of metformine and observe for 52 weeks

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

1. age>=20, <75
2. HbA1c>=6.5%, <10%
3. treated by 500-750 mg/day of metformine in addition to diet and exercise therapy
4. no need for additional drug for hypertension or dyslipidemia
5. written informed consent obtained

Key exclusion criteria

1. treated by insulin injection
2. unstable diabetic retinopathy
3. advanced liver, renal or cardiac disease(s)
4. allergy to metformine or ipraglyfrozine
5. (possible) pregnant or breast-feeding women
6. those with severe ketosis or diabetic (pre)coma
7. those with severe infection or trauma, or before/after sugery
8. those who are inappropriated for the present study

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Taku
Middle name
Last name Watanabe

Organization

Hokkaido University Hospital

Division name

First Department of Medicine

Zip code

0608638

Address

North 14, West 5, Kita-ku, Sapporo, 060-8648, Japan

TEL

011-706-5911

Email

takuwatanabe-circ@umin.ac.jp


Public contact

Name of contact person

1st name Taku
Middle name
Last name Watanabe

Organization

Hokkaido University Hospital

Division name

First Department of Medicine

Zip code

0608638

Address

North 14, West 5, Kita-ku, Sapporo, 060-8648, Japan

TEL

011-706-5911

Homepage URL


Email

takuwatanabe-circ@umin.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

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

Hokkaido University Hospital Clinical Research and Medical Innovation Center

Address

North 14, West 5, Kita-ku, Sapporo, 060-8648, Japan

Tel

+81117017636

Email

takuwatanabe-circ@umin.ac.jp


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 08 Month 30 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

No longer recruiting

Date of protocol fixation

2014 Year 08 Month 25 Day

Date of IRB

2014 Year 09 Month 17 Day

Anticipated trial start date

2014 Year 09 Month 17 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry

2019 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 27 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017411


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name