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

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 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

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

Value
https://center6.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