Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860288

Enrollment

1988

Registered

2009-03-12

Start date

2009-02-28

Completion date

2011-03-31

Last updated

2020-12-29

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

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Interventions

DRUGVildagliptin

DRUGMetformin

DRUGPlacebo

DRUGSitagliptin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

Healthy volunteers

Inclusion criteria

* Patients 18-78 years old inclusive at Visit 1 * T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1 * Patient agreement to maintain same dose of metformin throughout study * HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1 * Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion criteria

* Pregnant or nursing (lactating) women * FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment	24 weeks

Secondary

Measure	Time frame
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.	24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.	24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.	24 weeks
To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.	24 weeks
To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.	76 weeks
To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.	24 weeks
To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.	76 weeks

Countries

Argentina, Austria, Belgium, Finland, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Slovakia, South Korea, Venezuela

Outcome results

None listed

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