UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes
Title of the study (Brief title)	Patient satisfaction of combination therapy with lixisenatide and basal insulin
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the patient satisfaction level of combination therapy with lixisenatide and basal insulin with that of multiple insulin injection therapy in patients with uncontrolled type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diabetes Treatment Satisfaction Questionnaire(DTSQ) at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin
Key secondary outcomes	The daily profile of blood glucose, changes of HbA1c and body weight at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin Incidence of hypoglycemia

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	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lixisenatide group: In type 2 diabetic patients treated with multiple insulin injection therapy, discontinue rapid-acting insulin and add on lixisenatide at 20ug. Continue basal insulin.
Interventions/Control_2	Multiple insulin group: Continue multiple insulin injection therapy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients whose HbA1c were >=6.0%, <9.0%, type 2 diabetic patients 2) Patients treated with multiple insulin injection therapy for more than 3 months 3) Patients whose total dose of daily insulin were <=30 units.
Key exclusion criteria	1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months 2) Patients who are pregnant or in lactation period 3) Patients with serious infectious disease, before operation, serious trauma 4) Patients who receive steroid therapy 5) Patients with severe liver dysfunction 6) Patients with type 1 diabetes 7) Patients with disorder of insulin secretion whose fasting serum C-peptide <0.5ng/ml 8) Patients with hypersensitivity to these medicines 9) Patients who have history of pancreas disease 10) Patients who have history of cancer 11) Patients receiving with GLP-1 receptor agonist or he DPP-4 inhibitor in the past 3 months
Target sample size	34

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	North 15,West 7,Kita-ku,Sapporo,Hokkaido,060-8638
TEL	011-706-5915
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	Akinobu Nakamura
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	North 15,West 7,Kita-ku,Sapporo,Hokkaido,060-8638
TEL	011-706-5915
Homepage URL
Email	akinbo@tim.hi-ho.ne.jp

Sponsor
Institute	Hokkaido University Hospital
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	Hokkaido University Hospital
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	北海道大学病院（北海道） NTT東日本札幌病院（北海道） 帯広厚生病院（北海道） 釧路赤十字病院（北海道） 苫小牧市立病院（北海道） 沖医院（北海道） 栗原内科（北海道） 青木内科クリニック（北海道）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 06 Day
Anticipated trial start date	2013 Year 12 Month 25 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 25 Day
Last modified on	2016 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014835