Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study

Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study - BIRIKEN-2 Study (Blood glucose Investigation and Reduction In Kansai area by ENdocrinologist-2 Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000005994

Enrollment

500

Registered

2011-07-18

Start date

2010-07-01

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

Diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with type 2 diabetes who had received diet and exercise therapy or treatment with antidiabetic agents other than a DPP-4 inhibitor in addition to diet and exercise therapy for more than 1 month, and whose blood glucose has not been sufficiently controlled*. 2) Outpatients aged 20 years and above,, male and female. 3) Patients who have given written consent for the study

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. 1) Patients with type 1 diabetes 2) Patients who had a history of severe ketosis, diabetic coma or complete coma within previous 6 months 3) Patients before or after operation, and those with severe infections or serious injury 4) Patients with severe kidney dysfunction 5) Patients who had severe cardiovascular complications that require hospitalization within 6 months before signing the informed consent 6) Patients who are pregnant or maybe can pregnant and patients are lactating. 7) Patients with a history of hypersensitivity to the study drug 8) Patients who are considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

Measure	Time frame
Changes in HbA1c after 3 months from baseline	—

Secondary

Measure	Time frame
1) Changes and %changes in HbA1c after 3, 6, 12, 18 and 24 months from baseline in the following parameters (excluding the value after 3 months): Fasting blood glucose or postprandial blood glucose (optional) and body weight. 2) Exploratory analyses Stratified analyses by treatment (monotherapy vs combination therapy) and patient background (sex, baseline values, length of diabetes, BMI) etc. to identify patients who can benefit from glucose-lowering treatment with sitagliptin.	—

Measure

Time frame

1) Changes and %changes in HbA1c after 3, 6, 12, 18 and 24 months from baseline in the following parameters (excluding the value after 3 months): Fasting blood glucose or postprandial blood glucose (optional) and body weight. 2) Exploratory analyses Stratified analyses by treatment (monotherapy vs combination therapy) and patient background (sex, baseline values, length of diabetes, BMI) etc. to identify patients who can benefit from glucose-lowering treatment with sitagliptin.

—

Countries

Japan

Contacts

Public ContactHaruo Nishimura

Osaka Saiseikai Nakatsu Hospital Division of diabetes and endocrinology

23001@nakatsu.saiseikai.or.jp06-6372-0333

Outcome results