UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031157 |
|---|---|
| Receipt number | R000035545 |
| Scientific Title | Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2020/02/11 13:58:31 |
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Basic information
Public title
Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Acronym
Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Scientific Title
Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Scientific Title:Acronym
Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes with diabetic nephropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the long-term effects of ipragliflozin on the glycemic control, renal function and metabolic parameters in type 2 diabetic patients with diabetic nephropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c
Key secondary outcomes
Changes from baseline in urinary albumin-to-creatinine ratio (UACR), eGFR, blood pressure, body weight, fasting plasma glucose, fasting serum lipids, AST, ALT, and uric acid at week 104.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. Patients with type 2 diabetes
2. HbA1c higher than 6.5% and lower than 11.0%
3. BMI higher than 22 and lower than 45 kg/m2
4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and/or insulin therapy at baseline.
5. Patients who are able to provide written informed consent.
Key exclusion criteria
1. Patients who have history or current serious diabetic complication.
2. Patients that insulin dependence is suspected.
3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder.
4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
5. Patients who have hepatic dysfunction.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL
0493-72-2333
dito@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL
0493-72-2333
Homepage URL
dito@saitama-med.ac.jp
Sponsor or person
Institute
Ogawa Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogawa Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ipragliflozin 50 mg per day for 24 weeks.
After intervention therapy, patients returned to hospital based diabetes care according to their clinical needs.
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035545
