Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00728351

Enrollment

317

Registered

2008-08-05

Start date

2008-06-30

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin

Brief summary

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Interventions

DRUGvildagliptin + metformin

DRUGmetformin

1000 bid metformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

Healthy volunteers

Inclusion criteria

* History of T2DM treated with Metformin

Exclusion criteria

* FPG \>= 260 mg/dL (14.4mmol/L) Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy	24 weeks

Secondary

Measure	Time frame
FPG reduction	24 weeks
Safety and tolerability	24 weeks
Body weight change from baseline	24 weeks
Changes in the fasting lipid profile	24 weeks

Countries

France, Germany, Hungary, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026