UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the efficacy of combination therapy of insulin and ipragliflozin in patients with type 2 diabetes
Title of the study (Brief title)	A study on the efficacy of combination therapy of insulin and ipragliflozin in patients with type 2 diabetes
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 efficacy and safety of combination therapy in type 2 diabetes patients who are poorly controlled, nevertheless administrated insulin and DPP-4 inhibitor concomitantly
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change and percent change in HbA1c from baseline to 24 weeks
Key secondary outcomes	Change and percent change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for the change at 24 week) 2) Fasting plasma glucose,CPR, CPI 3) Body weight and waist circumference 4) Serum lipid (TC, LDL-C, TG, HLD-C) 5) Sitting blood pressure 6) Adiponectin, hs-CRP, TNF-alpha

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 24 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Aged 20 to 80 years at providing consent 2) Poorly glycemic controlled patients nevertheless who undergoes insulin and DPP-4 inhibitors combination therapy at least 12 weeks, or patients with DPP-4 inhibitor is interrupted and insulin solely treatment because of poorly glycemic control 3) HbA1c >= 7.0 and < 9.5% 4) BMI >= 22 kg/m2 5) Received informed consent
Key exclusion criteria	1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) Moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 5) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 6) Is receiving SGLT-2 inhibitor at initiation 7) Is nursing or pregnant or planned to become pregnant 8) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 9) Considered as inadequate by the investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Kenichi Imamura
Organization	Imamura clinic
Division name	Medical director
Address	2-1-1, Ooaza-matsubaranishi, Hirosaki City, Aomori, Japan
TEL	0172-88-3090
Email	kenichi_429@song.ocn.ne.jp

Public contact
Name of contact person	Kenichi Imamura
Organization	Imamura clinic
Division name	Medical director
Address	2-1-1, Ooaza-matsubaranishi, Hirosaki City, Aomori, Japan
TEL	0172-88-3090
Homepage URL
Email	kenichi_429@song.ocn.ne.jp

Sponsor
Institute	Imamura clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 16 Day
Anticipated trial start date	2014 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 08 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017210