UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018784 |
|---|---|
| Receipt number | R000021643 |
| Scientific Title | Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2018/07/30 21:38:56 |
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Basic information
Public title
Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial
Acronym
Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial
Scientific Title
Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial
Scientific Title:Acronym
Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ipragliflozin on pancreatic beta cell function in poorly controlled type 2 diabetic patients, who newly diagnosed or have treated with drugs except for SGLT2 inhibitor, by comparison of insulin monotherapy and combination therapy with ipragliflozin and insulin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Period to achieve target blood glucose levels
Key secondary outcomes
1. Changes in parameters of glucose metabolism
Total daily insulin dose, daily profile of blood glucose, plasma glucose, serum insulin and C-peptide and plasma glucagon levels during mixed-meal tolerance test
2. Changes in body weight and parameters
of body fluid volume
Body weight, waist circumstance, serum ketone body fraction, Hematocrit, serum ureanitrogen, uric acid and BNP, urinary ketone body
3. Changes in parameters of lipid metabolism
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride
4. Changes in parameters of renal function
Serum creatinine, urinary albumin and beta 2 microglobulin
5. Changes in parameters of bone metabolism
Serum Ca, P, Mg, PTH, 25(OH)VD, BAP, TRACP-5b, FGF23, urinary Ca, urinary P, urinary Mg
6. Incidence rate and severity of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with ipragliflozin and insulin group
Oral administration of 50mg ipragliflozin (Suglat) once a day, after breakfast
Multiple injection of rapid acting insulin (Novorapid flexpen) and long acting insulin (Levemir flextouch)
Interventions/Control_2
Insulin monotherapy group
Multiple injection of rapid acting insulin (Novorapid flexpen) and long acting insulin (Levemir flextouch)
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) HbA1c<=8.0% at the entry of the study
2) Patients treated with diet therapy only or drugs except for SGLT2 inhibitor
3) Patients provided written informed consent to participate in the study with their own will
Key exclusion criteria
1) Patients less than 20 years old or 75 years or older, and without consent
2) BMI<20kg/m2
3) Patients with severe diabetic complication (pre-proliferative retinopathy/proliferative retinopathy, eGFR<45ml/min/1.73m2, cardiovascular/cerebrovascular disease)
4) Patiens severe liver dysfunction (AST or ALT 100 IU/L or more, or T-Bil 2.0 mg/dl or more)
5) Patients who have malignant neoplasm
6) Patients taking glucocorticoid medicine
7) Patines with malnutrition or dehydration
8) Patients who correspond to the administration contraindication of ipragliflozin or insulin
9) Woman who are pregnant, nursing or possibly pregnant
10) Patients who considered not eligible for the study by the attending doctor due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Matsuoka |
Organization
Osaka university medical hospital
Division name
Department of Metabolic Medicine
Zip code
Address
2-15, yamadaoka, suita-shi, Osaka, 565-0871, Japan
TEL
06-6879-3732
matsuoka@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumie Sakamoto |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2, yamadaoka, suita-shi, Osaka, 565-0871, Japan
TEL
06-6879-3743
Homepage URL
http://www.med.osaka-u.ac.jp/pub/endmet/www/home/clinical.html
sakamoto131@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university medical hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪大学医学部附属病院（大阪府）、大阪警察病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
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
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021643
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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