The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study)

The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study) - Add Tofogliflozin to Oral anti-diabetic Medicine and once-daily Injection Combo (ATOMIC) Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016969

Enrollment

Registered

2015-03-30

Start date

2014-12-01

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

type 2 diabetes mellitus

Interventions

Until December 2016. Assign randomly to a group adding Tofogliflozin and a group not to add for each 3 months. The subcutaneous injection once a day both groups. For glargine group, the attending

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with HbA1c 7.0 to 10% (2) Patients who are registered in the clinical trial (UMIN000012224) (3) Adalts who are 20 years or older (4) 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

Measure	Time frame
1. difference of glucose improvement by taking Tofo or not 2. difference of glucose improvement by the injection method	—

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