Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes inadequately controlled by combination therapy with vildagliptin and low-dose metformin

Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes inadequately controlled by combination therapy with vildagliptin and low-dose metformin - Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes treated with with vildagliptin (Build Up Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013108

Enrollment

Registered

2014-02-08

Start date

2014-02-24

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

metformin dose up is done targeting HbA1c&lt

6.0% and maximum dose is 2250mg/day Standard treatment is continued. However, if control is above 7.0%, physicians can increase dose of metformin up tp 1000mg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Japanese patients with T2DM whose HbA1c 6.5-7.5% (NGSP) even after treatment with combination therapy of vildagliptin (50mg twice daily) and metformin (500-750mg/day) at least 3 months. 2) Over 20 and under 75 years old 3)male and female 4)3) written informed consent from each patient

Exclusion criteria

Exclusion criteria: 1) history of lactic acidosis 2) renal dysfunction 3)under hemodialysis 4)serious liver disease with >100 IU/L in AST and/or ALT 5) Type 1 diabetes 6) under insulin treatment 7) under treatment for cancer 8) proliferative diabetic retinopathy 9)Excess consumption of alcohol 10) gastrointestinal disorders such as diarrhea and vomiting concern to dehydration 11) severe ketosis and diabetic coma or pre-coma 12)serious infective diseases, serious injury, pre- and per-operation 13) during pregnancy and lactation. 14) hypersensitivity of vildagliptin and metformin 15) high dose metformin treatment (>750mg/day)

Design outcomes

Primary

Measure	Time frame
Changes of HbA1c from baseline	—

Secondary

Measure	Time frame
1)Target achievement rate of HbA1c (<6.0%) 2)Changes of insulin, glucagon, C-peptide, proinsulin/insulin rate, DPP-4 activity 3)Symptomatic hypoglycemic events and gastrointestinal disorders 4)inflammatory cytokines and lipid levels	—

Countries

Japan

Contacts

Public ContactAkio Kanazawa

Juntendo university Metabolism and Endocrinology

akana@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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