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 | 2025/08/25 22:52:29 |
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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 adding ipragliflozin with doubling metformin in Japanese adults with type 2 diabetes insufficiently controlled on low-dose metformin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The between-group difference in mean HbA1c change from baseline to week 52.
Key secondary outcomes
Body composition, metabolic biomarkers, adipokines, and safety outcomes, as well as subgroup analysis of HbA1c change by baseline HbA1c (<8.5% vs >=8.5%).
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In patients with type 2 diabetes currently receiving metformin 500 or 750 mg/day, the dose will be doubled and the patients will be observed for 52 weeks.
Interventions/Control_2
In patients with type 2 diabetes currently receiving metformin 500 or 750 mg/day, ipragliflozin 50 mg will be added, and the patients will be observed 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 >=0 and <75 years at the time of consent
2. HbA1c 6.5-10.0% (NGSP) at the time of consent, with no change in oral medications during the preceding 3 months
3. Patients with type 2 diabetes previously treated with diet and exercise plus 500-750 mg of metformin hydrochloride, or with additional oral hypoglycemic agents other than SGLT2 inhibitors as monotherapy or in combination
4. Patients whose blood pressure and lipid control are stable and for whom addition of new agents during the study period is not anticipated
5. Written informed consent obtained after sufficient explanation and understanding, based on the patient's free will
Key exclusion criteria
1. Patients treated with insulin
2. Patients whose diabetic retinopathy is not stable
3. Patients for whom participation is difficult due to severe hepatic, renal, cardiac, or respiratory disease (specifically: liver function >=2.5x upper limit of normal; renal function: serum creatinine >=1.3 mg/dL in men or >=1.2 mg/dL in women, or eGFR <30 mL/min/1.73 m2; or decreased cardiac/respiratory function)
4. Patients with a history of hypersensitivity to components of the study drugs
5. Pregnant or lactating women, or women who may be pregnant
6. Patients with severe ketosis, diabetic coma or pre-coma
7. Patients with severe infections, perioperative status, or serious trauma
8. Any other case judged by the principal or co-investigator to be unsuitable as a subject
Target sample size
144
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
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017411
