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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012224
Receipt No. R000014284
Scientific Title The examination of effects of switching to GLP-1 analog liraglutide or adding on insulin glargine once daily for type 2 diabetes controlled insufficiently by DPP-4 inhibitors and other oral anti-diabetic agents combination (multicenter study).
Date of disclosure of the study information 2013/11/06
Last modified on 2018/08/31

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Basic information
Public title The examination of effects of switching to GLP-1 analog liraglutide or adding on insulin glargine once daily for type 2 diabetes controlled insufficiently by DPP-4 inhibitors and other oral anti-diabetic agents combination (multicenter study).
Acronym Basal-supported Oral therapy Or Switching to GLP-1 receptor agonist for Type 2 diabetes (BOOST2) study
Scientific Title The examination of effects of switching to GLP-1 analog liraglutide or adding on insulin glargine once daily for type 2 diabetes controlled insufficiently by DPP-4 inhibitors and other oral anti-diabetic agents combination (multicenter study).
Scientific Title:Acronym Basal-supported Oral therapy Or Switching to GLP-1 receptor agonist for Type 2 diabetes (BOOST2) study
Region
Japan

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

Objectives
Narrative objectives1 For type 2 diabetes patients controlled inadequately with HbA1c 7.0 to 10.0%, taking oral anti-diabetic drugs including the DPP-4 inhibitors in addition to diet and exercise therapy for 12 weeks or more, to perform switching to human GLP-1 analog liraglutide or adding on long-acting insulin glargine once daily.
It is intended to be compared the incidence of adverse events such as hypoglycemia and usefulness in glycemic control between two groups in a multicenter.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. an achievement rate of less than HbA1c7.0%.
2. a reduction degree of the HbA1c.
Key secondary outcomes 3.the comparison of the HbA1c reduction degree by having combination or not of the sulfonylureas (SUs).
4.incidence of hypoglycemia
5.changes of body weight

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Until December 2015 (1 year extended).
Dose of liraglutide group starts at 0.3mg, the attending physician increased to 0.9mg by 0.3mg within 12 weeks by the increase done at the discretion of him at intervals of one week or more.
The subcutaneous injection once a day both groups.
Interventions/Control_2 Dose of glargine group starts from weight*0.1U/kg, the attending physician dose adjusted according to the algorithm.
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 (1) Patients with HbA1c 7.0 to 10%
(2) Patients being treated for more than 12 weeks Diet and exercise therapy
(3) Patients who is given oral anti-diabetic agents including the DPP-4 inhibitor more than 12 weeks
(4) Patients who does not use human GLP-1 analog or insulin
(5) Adalts who are 20 years or older
(6) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria (1) Type 1 diabetes mellitus patients
(2) Patients with severe liver disease
(3) Patients with severe renal disease
(4) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(5) Patients with severe pancreas disease
(6) Patients having a cancer
(7) Patients with hemoglobin (Hb) less than 11 g/dL
(8) Patients that the number of the platelets is less than 100,000 /mm3
(9) Patients with high diabetic neuropathy
(10) Patients having a proliferative retinopathy
(11) Patients with a serious infectious disease or a serious injury
(12) Patients with bowel disease or ileus factors
(13) Chronic enteropathy patients with the digestion and absorption abnormality
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant
(16) Patients who was infected with hepatitis B virus or hepatitis C virus
(17) In addition, the patient who judged inappropriate by an attendant physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Miyagi
Organization Toho University School of Medicine
Division name Division of diabetes, metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email miyagi-m@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Miyagi
Organization Toho University School of Medicine
Division name Division of diabetes, metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email miyagi-m@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization Toho University School of Medicine
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
Address
Tel
Email

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 大森赤十字病院内科(東京都),済生会横浜市東部病院糖尿病内分泌内科(神奈川県),ささもとクリニック(東京都),しんクリニック(東京都),たまき青空病院(徳島県),徳島県立中央病院糖尿病・代謝内科(徳島県),徳島大学糖尿病臨床・研究開発センター(徳島県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s13300-018-0486-1
Number of participants that the trial has enrolled
Results
For poorly controlled T2DM on DPP-4i-based OAD therapy, switching to single-dose liraglutide to enhance incretin signaling is as effective as dose-titrated basal IGlar, but significant BW reduction was only seen in the liraglutide group. 
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 Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 06 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 01 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 06 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014284

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/11/14 G-Lstudy_Analysis.xlsx


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