UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016563
Receipt No. 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 (Ver. 6)

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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
Email 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
Email nsato@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018614