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 | 2024/09/03 10:37:19 |
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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
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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
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
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
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
133
Results
Although there was no significant difference in HbA1c between the two groups, ipragliflozin may be more effective in anti-obesity effect and favorable changes in metabolic parameters than metformin.
Results date posted
| 2024 | Year | 09 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper in preparation
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
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017411
