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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024738
Receipt No. R000028462
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.
Date of disclosure of the study information 2016/11/07
Last modified on 2019/05/15

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000028462

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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