Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.

Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial. - Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033867

Enrollment

Registered

2018-09-01

Start date

2018-09-01

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

Take alogliptin 25 mg/metformin 500 mg combination tablet once a day. Evaluate parameters before and after the 12 weeks treatment period. Take vildagliptin 50 mg/metformin 250 mg combination tablet tw

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Outpatients 2) Type 2 diabetic patients who showed HbA1c levels 6.5 % to 10.0 % with anti-diabetic medications other than insulin therapy over 4 weeks before enrollment 3) Patients who showed written consent regarding participation in this study

Exclusion criteria

Exclusion criteria: 1) Contraindications to alogliptin, vildagliptin, and metformin 2) Diabetic patients with type 1 diabetes and other causes 3) Diabetic ketoacidosis 4) Patients with a history of severe hypoglycemia with coma or loss of consciousness 5) Severe infection, severe trauma 6) Patients with poorly controlled hypertension despite drug treatment 7) Severe renal, hepatic and heart disease 8) Proliferative retinopathy 9) Patients with a history of malignant tumors 10) Not suitable for participate in this study from serious complications judged by a doctor 11) Women with the potential to become pregnant or pregnant, and lactating women 12) Patients judged by doctors to be inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
The changes of HbA1c levels and fasting plasma glucose levels	—

Secondary

Measure	Time frame
1) Body weight, Waist circumference, Blood pressure 2) Fasting insulin and glucagon concentrations 3) Homeostasis model assessment-insulin resistance (HOMA-IR), Homeostasis model assessment of beta cell function (HOMA-beta), Serum lipids 4) Blood glucose area and blood glucose fluctuation index by flash glucose monitoring (FGM)	—

Countries

Japan

Contacts

Public ContactYasutaka Takeda

Asahikawa Medical University Division of Metabolism and Biosystemic Science, Department of Internal Medicine

yktake5@asahikawa-med.ac.jp0166-68-2454

Outcome results

None listed

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