UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Takaaki Matsuoka
Organization	Osaka university medical hospital
Division name	Department of Metabolic Medicine
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	Fumie Sakamoto
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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