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Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration

Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration - Comparison of order of SGLT-2 inhibitor and DPP-4 inhibitor administration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021658
Enrollment
60
Registered
2016-05-01
Start date
2016-01-01
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

Interventions

After luseogliflozin 2.5 mg monotherapy for 3 months, sitagliptin 50 mg is concomitantly administered for 3 months After sitagliptin 50 mg monotherapy for 3 months, luseogliflozin 2.5 mg is concomit

Sponsors

Miura Central Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: "1) Type 2 diabetes mellitus patients on diet and exercise therapy with inadequate blood glucose control 2) More than 20 years of age at the time of informed consent acquisition 3) Both females and males 4) Patients whose HbA1c (NGSP values) is more than 6.5% 5) Patients who received explanation of the study by using an informed consent form and gave written consent on study participation "

Exclusion criteria

Exclusion criteria: "1) Patients with type 1 diabetes mellitus 2) Patients who had severe ketosis, diabetic coma, or precoma within 6 months 3) Patients with severe infection, perioperative patients, patients with severe trauma 4) Patients hypersensitive to ingredients of the drug used or its excipient 5) Patients with severe renal dysfunction (eGFR < 30 ml/min/1.73 m2) or terminal renal failure patients undergoing dialysis 6) Patients with severe hepatic dysfunction 7) Patients who are pregnant or breast-feeding 8) Patients considered inappropriate to participate in the study by the principal (sub-) investigator "

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1c

Secondary

MeasureTime frame
Blood glucose (fasting), IRI, CPR, Glucagon, Leptin, diponectin, TG, TC, LDL-C, HDL-C, ALT (GPT), AST (GOT), GGT, Uric acid, Creatinine, L-FABP, Urine microalbumin, Blood pressure, Body weight, Questionnaire (patient satisfaction, etc.)

Countries

Japan

Contacts

Public ContactMasahiro Takihata

Miura Central Clinic internal medicine

takihata-hki@umin.ac.jp046-888-5010

Outcome results

None listed

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