UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018084 |
|---|---|
| Receipt number | R000020929 |
| Scientific Title | SGLT2 Inhibitor, Ipragliflozin, Suglat, Effect on Lipid and Glucose Metabolism Study |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2024/04/19 14:56:45 |
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Basic information
Public title
SGLT2 Inhibitor, Ipragliflozin, Suglat, Effect on Lipid and Glucose Metabolism Study
Acronym
SUCRE Study
Scientific Title
SGLT2 Inhibitor, Ipragliflozin, Suglat, Effect on Lipid and Glucose Metabolism Study
Scientific Title:Acronym
SUCRE Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the type 2 diabetic patients under the insufficient control of diabetes with no-insulin therapy, the glucose and lipid metabolism were studied after treatment with Ipragliflozin (Suglat) or DPP4 inhibitor (Sitagliptin). The each treatment would be kept for 1 year and the differences of clinical conditon would be compared between the two kinds of therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The changes of lipids metabolism marker (apolipoproteins including apo B48, AI, AII, B, CII, CIII, E), serum lipids, and the markers of cholesterol synthesis (lathosterol) and aborption (campesterol, sitosterol, and cholestanol) would be compared between SGLT2 inhibitor and DPP4 inhibitor treatment.
Key secondary outcomes
The changes of body weight and BMI.
The changes of glucose control; HbA1c, fasting blood glucose, glycoalbumin (GA), serum insulin).
Miscellaneous; serum ketones, liver function (AST, ALT, ganmma GTP, LDH), electrolytes (Na, K, CL), urate, creatini kinase, sistatin C, fatty acids (EPA and arachidonic acid), complement, and urinary albumn-to-creatinin ratio, leptin, and the peripheral blood cell counts.
The comparison in the frequensy of the cases controled under the target level os HbA1c (<7.0%), and of the cases added with the other agents to get a good control, and of the cases with body weight reduction.
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
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
Group A- Ipraglifrojin group (n=100); 50mg/day of ipraglifrojin would be administered, and the blood sample was prepared at the start, 1, 3 and 6 months after the treatment. The dose up to 100mg/day would be permitted as the doctors' judgement after 3 months treatment. In the case with hypoglycemia, the drug dose should be decreased as the Doctors' judgement. The other drug would be added by the doctors' judgement.
Interventions/Control_2
Group B-As control sitagliptiin group (n=100); 50mg/day of ipraglifrojin would be administered, and the blood sample was prepared at the start, 1, 3 and 6 months after the treatment. The dose up to 100mg/day would be permitted as the doctors' judgement after 3 months treatment. In the case with hypoglycemia, the drug dose should be decreased as the Doctors' judgement. The other drug would be added by the doctors' judgement.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The type 2 diabetic patients under the not-well dlycemic control even if the diet/excise therapy was addressed more than 1 month.
The HbA1c levels (7-10.5%) would be stable within 1% during the observation term, 2 months.
The eGFR would be maintainedover than 45mL/min.
BMI over than 20. The signature of each patient should be obtained after the written informed consent.
Key exclusion criteria
Type 1 diabetes. The treatment with insulin, GLP-1, DPP4 inhibitors, SGLT2 inhibitors, hypolipidemic agents, diuretics, steroids, or immunosuppressants. The past history of severe ketosis, diabetic pre-coma and coma. The cases complicated with proliferative retinopathy, dysuria, infectious diseases of urinary tract or genitals, severe infectious diseases, perioperative period, severe trauma, pregnant or the chance of pregnancy, lactational phase, severe liver disorder (Child-Pugh Grade Score 10-15), cerebral vascular diseases/unstable angina/myocardial infarction/angioplasty within 6 months, or the past history of severe heart diseases (NYHA Class III-IV). The patients were judged as the inappropriate cases for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Diabetes-Lifestyle Disease Center
Zip code
2048522
Address
3-1-24 Matsuyama, Kiyose, Tokyo
TEL
042-491-4111
shinichi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Diabetes-Lifestyle Disease Center
Zip code
204-8522
Address
3-1-24 Matsuyama, Kiyose, Tokyo
TEL
042-491-4111
Homepage URL
shinichi@nms.ac.jp
Sponsor or person
Institute
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Address
3-1-24 Matsuyama, Kiyose, Tokyo
Tel
042-491-4111
shom@fkujuji.org
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
複十字病院(東京都)，日本医科大学付属病院（東京都）、むとう内科医院（北海道）、士別市立病院（北海道）、カレスさっぽろ北光記念病院（北海道）、さの医院（山形県）、中島内科クリニック(東京都)、いしかわ日暮里クリニック（東京都）、医療法人社団亮敬会 板垣医院（東京都）、奥田クリニック（東京都）、かとうクリニック（東京都）、くまのまえ医院（東京都）、森谷医院（東京都）、斉藤医院（東京都）、吉行医院（東京都）、上尾中央総合病院（埼玉）、加藤メディカルクリニック(東京都)、東京慈恵会医科大学（東京都）、御所病院（福岡県）、福岡赤十字病院（福岡県）、乙成内科医院（福岡県）、佐賀記念病院（佐賀県）、大久保病院（大分県）、Tsukasa Health Care Hospital（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | 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
175
Results
Ipraglifrozn treatment increased HDL-C, and sitagliptin treatment decreased apo B48 levels. These effects may be a drug effect, because there were no differences in glycemic control between ipraglifrozin and sitagliptin therapy.
Results date posted
| 2023 | Year | 12 | Month | 31 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Now, the manuscript was submitted and major revision was sent. We are going to revise the manuscript.
Date of the first journal publication of results
Baseline Characteristics
generak physician
Participant flow
Adverse events
There are no differences in adverse effects between ipragliflozin and sitagliptin treatment.
Outcome measures
glycemic control , lipid metabolism, renal function, liver function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020929
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