Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study

Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study - Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031837

Enrollment

Registered

2018-03-22

Start date

2018-03-22

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. Vildagliptin 100 mg are started to use from day3 and dose of metformin increases (500 to 1000 mg) from day5. Then, vildagliptin is washed out and metfo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: type 2 diabetic patients medicated metformin 500 mg + basal-bolus insulin therapy of Glargine300+glulisine 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 time (hour) [mean glucose level (0:00-8:00, every 1 hour)] 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 time (hour) [mean glucose level (0:00-8:00, every 1 hour)] 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 Diabetes

souichi19811225@yahoo.co.jp0568-62-8111

Outcome results

None listed

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