UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Glucose-lowering effect of insulin glargine 300 U/ml in Japanese type 2 diabetic patients treated with basal-bolus insulin therapy
Title of the study (Brief title)	Glucose-lowering effect of insulin glargine 300 U/ml in Japanese 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 invesitgate daily profiles of glucose levels under insulin glargine 300 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 after injection of insulin glargine 300 U/ml
Key secondary outcomes

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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Injecting insulin glargine 300 U/ml once daily until 5 weeks after insulin dosage is fixed.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	- adults with type 2 diabetes mellitus - treated with basal-bolus insulin therapy - living a well-regulated life - time interval between breakfast and lunch, lunch and dinner, and dinner and breakfast was 6, 6, and 12 hours, respectively, with a tolerance of +/- 3 hours
Key exclusion criteria	- treated with antidiabetic drugs other than insulin - difficulty to perform self-monitoring of blood glucose - severe hepatic, renal and/or cardiac disease - hypersensitivity to insulin glargine 300 U/ml - 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

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	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 10 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 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	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022379