Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy

Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy - Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019833

Enrollment

Registered

2015-11-18

Start date

2015-12-01

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

Interventions

After receiving mitiglinide for two days, patients receive mitiglinide / voglibose combination tablets for two days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes mellitus patients who are receiving intensive insulin therapy 2) Age >=20 years at the time of obtaining consent 3) Hospitalized patients 4) Patients whose glucose toxicity had resolved as judged by the investigator or sub-investigator (e.g., blood glucose level <150 mg/dL at 4 time points throughout a day; namely, before breakfast, before lunch, before dinner, and before going to bed) 5) Patients who are receiving <20 units/day of additional insulin 6) Patients who provided written consent

Exclusion criteria

Exclusion criteria: 1) Patients who are taking other antidiabetes agents than insulin 2) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combination tablets based on their package inserts 3) Patients who were judged to be ineligible by the investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
1) Mean amplitude of glycemic excursions (MAGE) 2) Mean blood glucose level 3) Standard deviation (SD) of blood glucose level 4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL 5) Maximum and minimum blood glucose levels 6) Incidence of symptomatic hypoglycemia 7) Rate of glucose level <70 mg/dL 8) Blood glucose levels 1 and 2 h after every meal 9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent	—

Measure

Time frame

1) Mean amplitude of glycemic excursions (MAGE) 2) Mean blood glucose level 3) Standard deviation (SD) of blood glucose level 4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL 5) Maximum and minimum blood glucose levels 6) Incidence of symptomatic hypoglycemia 7) Rate of glucose level <70 mg/dL 8) Blood glucose levels 1 and 2 h after every meal 9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent

—

Countries

Japan

Contacts

Public ContactHideki Kamiya

Aichi Medical University Division of Diabetes

hkamiya@aichi-med-u.ac.jp0561-63-1683

Outcome results

None listed

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