Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01224366

Enrollment

448

Registered

2010-10-20

Start date

2010-09-30

Completion date

2011-10-31

Last updated

2017-02-23

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Add-on to insulin

Brief summary

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Interventions

DRUGVildagliptin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of T2DM * On a stable dose of insulin as defined by the protocol * On a stable does of metformin (if applicable) as defined by the protocol * Age 18 to 80 years * HbA1c of 7.5 to 11.0% * Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion criteria

* Type 1 diabetes * Short-acting or rapid-acting insulin * Pregnancy or lactation * Evidence of serious diabetic complications * Evidence of serious cardiovascular complications * Laboratory value abnormalities as defined by the protocol * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
HbA1c reduction	24 weeks

Secondary

Measure	Time frame
HbA1c reduction in subpopulation treated with insulin and with metformin	24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin	24 weeks
Reduction in FPG (overall and subpopulations)	24 weeks
Responder rates (overall and subpopulations)	24 weeks
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)	24 weeks

Countries

Australia, Belgium, Czechia, Germany, Guatemala, Hong Kong, Hungary, India, Romania, Slovakia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026