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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).

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012224
Enrollment
60
Registered
2013-11-06
Start date
2013-11-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. an achievement rate of less than HbA1c7.0%. 2. a reduction degree of the HbA1c.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMasahiko Miyagi

Toho University School of Medicine Division of diabetes, metabolism and endocrinology

miyagi-m@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026