UMIN-CTR Clinical Trial

Basic information
Public title	The study of algorithm for insulin dose after the change to insulin glargine U300 (LANTUS-XR) for type 2 diabetic patients with poor glucose control under insulin therapy.
Acronym	ISLAND STUDY
Scientific Title	The study of algorithm for insulin dose after the change to insulin glargine U300 (LANTUS-XR) for type 2 diabetic patients with poor glucose control under insulin therapy.
Scientific Title:Acronym	ISLAND STUDY
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess usefulness of self-titration based on self-monitoring blood glucose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The percentage of cases where the absolute value improved by 1% or more or 10% or more from baseline HbA1c
Key secondary outcomes	fasting glucose level, weight change, Insulin dose

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Self-titration group The attending physician changed Lantus to U300 without changing insulin dose at fisrt. Each patient in this group was instructed on SMBG and the algorithm of this study. The algorithm of this study as follows: each patient measured fasting blood glucose every day. Patient aged 65 years and older increase their dose of U300 by one Units per day if fasting blood glucose level was 110 mg/dl or higher 3 consecutive days, Patient aged less than 65 years increase their dose of U300 by one Units per day if fasting blood glucose level was 100 mg/dl or higher 3 consecutive days.
Interventions/Control_2	Physician lead group The attending physician changed Lantus to U300 without changing insulin dose. Each patients used self-monitoring of blood glucose to estimate their glycemic status. Each patient in this group injected same dose of insulin U300 until the next hospital visit. The physician changed the U300 dose every one month visit using .their SMBG data and HbA1c
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	10 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes mellitus undertreatment for LUNTUS
Key exclusion criteria	Dementia Type 1 diabetes mellitus Patient with GAD antibody Hypoglycemia Hypersensitivity to LANTUS Pregnant Severe liver dysfunction Severe renal dysfunction
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Tetsuji Middle name Last name Niiya
Organization	Matsuyama shimin hospital
Division name	Internal Medicine
Zip code	790-0067
Address	Otemachi, Matsuyama, Ehime
TEL	81-89-943-1151
Email	t.niiya@matsuyama-shimin-hsp.or.jp

Public contact
1st name of contact person	1st name Tetsuji Middle name Last name Niiya
Organization	Matsuyama shimin Hospital
Division name	Internal Medicine
Zip code	790-0067
Address	Otemachi, Matsuyama, Ehime
TEL	81-89-943-1151
Homepage URL
Email	t.niiya@matsuyama-shimin-hsp.or.jp

Sponsor
Institute	Matsuyama shimin hospital
Institute
Department

Funding Source
Organization	Matsuyama shimin hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Matsuyama Shimin Hospital
Address	6-6-5, 2tyoume, Ootemachi, Matsuyama
Tel	089-943-1151
Email	t.niiya@matsuyama-shimin-hsp.or.jp

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 11 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 11 Month 07 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date	2019 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 07 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028462