UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Title of the study (Brief title)	Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
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 efficacy and safety between injecting insulin glargine 300 U/ml before breakfast and injecting insulin glargine 100 U/ml before breakfast in type 2 diabetic patients treated with a basal insulin and a GLP-1 receptor agonist
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	glucose-lowering effect evaluated with HbA1c levels after three-month treatment
Key secondary outcomes	- glucose-lowering effect evaluated with self-monitored blood glucose levels - Subjective assessment of insulin injection - Adverse events including hypoglycemia, weight gain, and other side effects

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Injecting insulin glargine 100 U/ml before breakfast in period 1, and insulin glargine 300 U/ml before breakfast in period 2.
Interventions/Control_2	Injecting insulin glargine 300 U/ml before breakfast in period 1, and insulin glargine 100 U/ml before breakfast in period 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- adults with type 2 diabetes - treated with a basal insulin - treated with a GLP-1 receptor agonist (regardless of couse of oral hypoglycemic agents)
Key exclusion criteria	- patients injecting bolus insulin - patients expected to have other antidiabetic agents added, changed, or increased/decreased in dosage during the next 6 months - difficulty to perform self-monitoring blood glucose - Patients with severe hepatic, renal, and/or cardiac disease - Patients with hypersentitivity to the agents used in the current study - Patients who are pregnant, breast-feeding or may become pregnant - Patients who are judged by the investigator to be inappropriate for this study for any other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	Toshihiko Shiraiwa
Organization	Shiraiwa Medical Clinic
Division name	Shiraiwa Medical Clinic
Address	4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL	072-971-1221
Email	shiraiwa@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	Toshihiko Shiraiwa
Organization	Shiraiwa Medical Clinic
Division name	Shiraiwa Medical Clinic
Address	4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL	072-971-1221
Homepage URL
Email	shiraiwa@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Shiraiwa Medical Clinic
Institute
Department

Funding Source
Organization	Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka University Graduate School of Medicine
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	2015 Year 10 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 16 Day
Anticipated trial start date	2015 Year 10 Month 14 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	2015 Year 10 Month 14 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022381