Unique ID issued by UMIN | UMIN000012224 |
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Receipt number | 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 18:00:06 |
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).
Basal-supported Oral therapy Or Switching to GLP-1 receptor agonist for Type 2 diabetes (BOOST2) study
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).
Basal-supported Oral therapy Or Switching to GLP-1 receptor agonist for Type 2 diabetes (BOOST2) study
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
1. an achievement rate of less than HbA1c7.0%.
2. a reduction degree of the HbA1c.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
Dose of glargine group starts from weight*0.1U/kg, the attending physician dose adjusted according to the algorithm.
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
60
1st name | |
Middle name | |
Last name | Masahiko Miyagi |
Toho University School of Medicine
Division of diabetes, metabolism and endocrinology
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
03-3762-4151
miyagi-m@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Masahiko Miyagi |
Toho University School of Medicine
Division of diabetes, metabolism and endocrinology
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
03-3762-4151
miyagi-m@med.toho-u.ac.jp
Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Toho University School of Medicine
Self funding
NO
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)
2013 | Year | 11 | Month | 06 | Day |
Published
https://doi.org/10.1007/s13300-018-0486-1
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.
Completed
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 11 | Month | 06 | Day |
2016 | Year | 07 | Month | 31 | Day |
2017 | Year | 01 | Month | 31 | Day |
2017 | Year | 01 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2013 | Year | 11 | Month | 06 | Day |
2018 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014284
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2018/11/14 | G-Lstudy_Analysis.xlsx |