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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018784
Receipt No. 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

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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
Email 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
Email sakamoto131@endmet.med.osaka-u.ac.jp

Sponsor
Institute Osaka university medical hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021643

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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