Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study

Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study - Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029881

Enrollment

Registered

2017-11-08

Start date

2017-11-08

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

FreeStyle Libre Pro is attached after admission. Metformin 500 mg are started to use from day3 and dose of Glargine300 increases from day5. Then, dose of Glargine300 increases from day10 and Metformin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: type 2 diabetic patients medicated Vildagliptin 100 mg+Glargine300 for 3 month or longer

Exclusion criteria

Exclusion criteria: renal dysfunction (patients whose estimated glomerular filtration rate was less than 45 ml/min/1.73m2) judged to be unsuitable for participation for medical reasons

Design outcomes

Primary

Measure	Time frame
15% reduction achieving number of days [mean glucose level (24:00)]	—

Secondary

Measure	Time frame
15% reduction achieving number of days [mean glucose level (0:00-8:00)] 15% reduction achieving number of days [mean glucose level (8:00-24:00)] 15% reduction achieving number of days [SD (0:00-8:00)] 15% reduction achieving number of days [SD (24:00)] 15% reduction achieving number of days [SD (8:00-24:00)] Glycemic variability percentage (GVP) from the day before intervention start to 15% reduction achieving	—

Measure

Time frame

15% reduction achieving number of days [mean glucose level (0:00-8:00)] 15% reduction achieving number of days [mean glucose level (8:00-24:00)] 15% reduction achieving number of days [SD (0:00-8:00)] 15% reduction achieving number of days [SD (24:00)] 15% reduction achieving number of days [SD (8:00-24:00)] Glycemic variability percentage (GVP) from the day before intervention start to 15% reduction achieving

—

Countries

Japan

Contacts

Public ContactSoichi Takeishi

General Inuyama Chuo Hospital Department of Diabetes

souichi19811225@yahoo.co.jp0568-62-8111

Outcome results

None listed

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