UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016563 |
|---|---|
| Receipt number | R000018614 |
| Scientific Title | Efficacy and safety of the combination therapy with Ipragliflozin for the cases who have insufficient effect by oral hypoglycemic agents |
| Date of disclosure of the study information | 2015/02/17 |
| Last modified on | 2020/06/19 18:34:26 |
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Basic information
Public title
Efficacy and safety of the combination therapy with Ipragliflozin for the cases who have insufficient effect by oral hypoglycemic agents
Acronym
Effect of Ipragliflozin combination
Scientific Title
Efficacy and safety of the combination therapy with Ipragliflozin for the cases who have insufficient effect by oral hypoglycemic agents
Scientific Title:Acronym
Effect of Ipragliflozin combination
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy for glycemic control, weight loss, cardiovascular disease and renal failure of Ipragliflzin, a selective SGLT2 inhibitor, under combination with other oral hypoglycemic agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
fasting plasma glucose, body weight, blood pressure, waist circumference, body mass index, muscle mass, subcutaneous fat area size, visceral fat area size, cardio ankle vascular index, serum cystatin-C, urinary cystatin-C, SAA-LDL, leptin, adiponectin, high sensitive CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
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
Conventional treatment + Ipragliflozin [50mg/1day]
Interventions/Control_2
Conventional treatment
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.Type 2 diabetes mellitus
2.The cases who has insufficient glycemic control for more than 12 weeks after the treatment oral hypoglycemic agents
3.BMI:more than 22 kg/m2
4.HbA1c:6.5% to less than 9.0%
5.Subject have a diet and exercise therapy
6.Outpatient
Key exclusion criteria
1.Type 1 diabetes mellitus
2.Subjects with severe ketosis, diabetic coma or precoma
3.Subjects with severe infection, before and after surgery or severe injury
4.Subjects with severe hepatic dysfunction
5.Subjects with moderate renal dysfunction (Serum creatinine: more than 1.5mg/dL in male, more than 1.3mg/dL in female)
6.The subjects within the past 6 months, developed stroke, myocardial infarction, or other serious vascular complications requiring hospitalization
7.Sunjects with dehydration, diarrhea, vomiting or gastrointestinal injury
8.Subjects in SGLT-2 inhibitors, insulin formulation, GLP-1 receptor agonist prescription
9.Subjects in pregnant women, lactating women, the potential or planned are pregnant
10.Subjects with a history of hypersensitivity to SGLT-2 inhibitor
11.Subjects who have been determined to be unsuitable for the attending physician
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute for Endocrine Metabolic Diseases
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
nsato@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute for Endocrine Metabolic Diseases
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharama 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
The ethics committee for human research at Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan
Tel
075-641-9161
nsato@kyotolan.hosp.go.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
独立行政法人 国立病院機構 京都医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/59/5/59_3473-19/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/59/5/59_3473-19/_article
Number of participants that the trial has enrolled
32
Results
The patients' diminished estimated glomerular filtration rate (eGFR) was alleviated in the ipragliflozin group compared to the control group prior to significant improvements in HbA1c and other parameters, including anthropometric indices and arterial stiffness. Furthermore, ipragliflozin add-on therapy resulted in a greater reduction in serum UA levels than control therapy. The changes in the eGFR with ipragliflozin treatment were associated with ipragliflozin-mediated changes in the UA.
Results date posted
| 2020 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 60.7[12.3] years, 50% were women, and the mean HbA1c was 7.1[0.6]% (53.7[6.3] mmol/mmol). The baseline characteristics were reasonably similar between the two groups, except that the values of CAVI were higher in the control group than in the ipragliflozin group.
Participant flow
During the 12-month recruitment period, 32 patients were screened. Two withdrew their consent before randomization, so 30 patients were randomly assigned to the ipragliflozin and control groups (n=15 each). One patient in the ipragliflozin group dropped out because of a scheduling conflict; the other 14 completed the 12-week intervention period. Two patients in the control group dropped out (1 withdrew, and the other had a scheduling conflict), leaving 13 who completed the study.
Adverse events
The treatment was not changed for any participant during the study period, and no adverse events were observed in either group.
Outcome measures
The patients' diminished estimated glomerular filtration rate (eGFR) was alleviated in the ipragliflozin group compared to the control group prior to significant improvements in HbA1c and other parameters, including anthropometric indices and arterial stiffness. Furthermore, ipragliflozin add-on therapy resulted in a greater reduction in serum UA levels than control therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018614
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