UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Insulin glargine 300 U/ml versus insulin degludec 100 U/ml in type 2 diabetic patients treated with basal-bolus insulin therapy
Title of the study (Brief title)	Insulin glargine 300 U/ml versus insulin degludec 100 U/ml in type 2 diabetic patients treated with basal-bolus insulin therapy
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 insulin glargine 300 U/ml and insulin degludec 100 U/ml in type 2 diabetic patients treated with basal-bolus insulin therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	daily profiles of glucose levels
Key secondary outcomes

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	insulin glargine 300 U/ml (dose-adjustment period + 5-week blood glucose-assessment period) at the first term and insulin degludec 100 U/ml (dose-adjustment period + 5-week blood glucose-assessment period) at the second term
Interventions/Control_2	insulin degludec 100 U/ml (dose-adjustment period + 5-week blood glucose-assessment period) at the first term and insulin glargine 300 U/ml (dose-adjustment period + 5-week blood glucose-assessment period) at the second term
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 mellitus - patients treated with basal-bolus insulin therapy - patients with regular lifestyle. - patients whose time interval between breakfast and lunch, lunch and dinner, and dinner and breakfast are 6, 6, and 12 hours, respectively, with a tolerance of +/- 3 hours.
Key exclusion criteria	- treated with anti-diabetic agents other than insulin - difficult to perform self-monitoring of blood glucose - severe hepatic, renal and/or cardiac disease - hypersensitivity to insulin degludec and/or insulin glargine - pregnant or breast-feeding females. - Patients who are judged by the investigator to be inappropriate for this study for any other reason.
Target sample size	40

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
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 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 16 Day
Anticipated trial start date	2015 Year 12 Month 01 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 11 Month 28 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=R000023057