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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014963
Receipt No. R000017411
Official scientific title of the study 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 2017/03/01

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Basic information
Official scientific title of the study Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Taku Watanabe
Organization Hokkaido University Hospital
Division name First Department of Medicine
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 Taku Watanabe
Organization Hokkaido University Hospital
Division name First Department of Medicine
Address North 14, West 5, Kita-ku, Sapporo, 060-8648, Japan
TEL 011-706-5911
Homepage URL
Email takuwatanabe-circ@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 08 Month 25 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 08 Month 27 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017411


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