Status:
COMPLETED
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT01224366
Start Date
September 1 2010
End Date
October 1 2011
Last Update
February 23 2017
Active Locations (66)
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1
Novartis Investigative Site
Box Hill, Australia
2
Novartis Investigative Site
Heidelberg Heights, Australia
3
Novartis Investigative Site
Parkville, Australia
4
Novartis Investigative Site #1
Wollongong, Australia