UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Title of the study (Brief title)	The analysis of the impact of basal insulin stabiity on day-by-day blood glucose variability
Region	Japan

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

Objectives
Narrative objectives1	The aim of this crossover study, comparison of long and conventional acting basal insulin, is to evaluate the effect on day-by-day blood glucose variability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The average of 2 times of mean of daily differences (MODD)
Key secondary outcomes	Day-by-day variability of fasting blood glucose

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	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	In the first course, insulin glargine U100 is used for 4 weeks. After the treatment of insulin glargine U100, the CGM examination is underwent. In the second course, insulin glargine U300 is used for 4 weeks. After the treatment of insulin glargine U300, the CGM examination is underwent. Insulin dose is adjusted at the beginning and 2 weeks of each course according to the titration method.
Interventions/Control_2	In the first course, insulin glargine U300 is used for 4 weeks. After the treatment of insulin glargine U300, the CGM examination is underwent. In the second course, insulin glargine U100 is used for 4 weeks. After the treatment of insulin glargine U100, the CGM examination is underwent. Insulin dose is adjusted at the beginning and 2 weeks of each course according to the titration method.
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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Type 2 diabetic patient who has injected glargine U100 for more than 12 weeks. 2) HbA1c less than 9% within 4 weeks prior to entry 3) Patient who can undergo self monitoring blood glucose before each insulin injection and equip continuous glucose monitoring
Key exclusion criteria	1) severe ketosis, coma, or reduced level of con- sciousness due to diabetes within the past 6 months 2) Patients who may have been pregnant or pregnant women 3) Patients with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) 4) Patients with moderate or severe renal dysfunction (BUN more than 25mg/dL or serum creatinine more than 2.0 mg/dL)
Target sample size	16

Research contact person
Name of lead principal investigator	Masaya Sakamoto
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	m-sakamoto@umin.ac.jp

Public contact
Name of contact person	Masaya Sakamoto
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	m-sakamoto@umin.ac.jp

Sponsor
Institute	Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
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	Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
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	2016 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 04 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	2016 Year 01 Month 07 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023555