UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024738 |
|---|---|
| Receipt number | 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 20:31:47 |
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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
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
t.niiya@matsuyama-shimin-hsp.or.jp
Sponsor or person
Institute
Matsuyama shimin hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028462
