UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Title of the study (Brief title)	Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Region	Japan

Condition
Condition	type 1 diabetes or type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the glucose-lowering effect and glycemic variability of insulin glargine with those of insulin degludec using continuous glucose monitoring (CGM).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0 mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10). The AUC is calculated using the trapezoidal method. Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE). Day-to-day glycemic variability is assessed as the mean of daily difference (MODD). Hypoglycemia, which is defined as a sensor value of <3.9 mmol/L, was also calculated as a total time at <3.9 mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8 mmol/L.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	The patient's prior long-acting insulin analog is discontinued and replaced with insulin glargine. The CGM examination is carried out at least 14 days after switching insulin. Insulin glargine is changed to insulin degludec when the first CGM examination end. Basically, the dose of insulin degludec is the same as that of insulin glargine.
Interventions/Control_2	The patient's prior long-acting insulin analog is discontinued and replaced with insulin degludec. The CGM examination is carried out at least 14 days after switching insulin. Insulin degludec is changed to insulin glargine when the first CGM examination end. Basically, the dose of insulin glargine is the same as that of insulin degludec.
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	Diabetic patients who were prescribed basal-bolus insulin therapy with long-acting insulin analog as basal insulin.
Key exclusion criteria	Patients with diabetic nephropathy more than stage 3 (urinary albumin 300mg/gCr or urinary protein 0.5g/gCr) or with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Yamada Satoru
Organization	Kitasato University Kitasato Institute Hospital
Division name	Diabetes Center
Address	5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL	03-3444-6161
Email	yamada-s@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Inoue Gaku
Organization	Kitasato University School of Pharmacy
Division name	Center for Clinical Pharmacy and Clinical Sciences
Address	5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL	03-5791-6359
Homepage URL
Email	inoueg@pharm.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization	Kitasato University School of Pharmacy
Organization
Division
Category of Funding Organization	Other
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	2014 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 15 Day
Anticipated trial start date	2013 Year 05 Month 21 Day
Last follow-up date	2016 Year 03 Month 11 Day
Date of closure to data entry	2016 Year 03 Month 11 Day
Date trial data considered complete	2016 Year 03 Month 11 Day
Date analysis concluded	2016 Year 05 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://journals.sagepub.com/doi/10.1177/1932296814564396
Results
Other related information

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2018 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015395