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.
1 other identifier
interventional
448
11 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Sep 2010
Shorter than P25 for phase_3 type-2-diabetes-mellitus
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 23, 2017
February 1, 2017
1.1 years
October 18, 2010
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c reduction
24 weeks
Secondary Outcomes (5)
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
Study Arms (2)
Vildagliptin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (66)
Novartis Investigative Site
Box Hill, Australia
Novartis Investigative Site
Heidelberg Heights, Australia
Novartis Investigative Site
Parkville, Australia
Novartis Investigative Site #1
Wollongong, Australia
Novartis Investigative Site #2
Wollongong, Australia
Novartis Investigative Site
Bonheiden, Belgium
Novartis Investigative Site
Edegem, Belgium
Novartis Investigative Site
Genk, Belgium
Novartis Investigative Site
La Louvière, Belgium
Novartis Investigative Site
Ronse, Belgium
Novartis Investigative Site #1
Ostrava, Czechia
Novartis Investigative Site #2
Ostrava, Czechia
Novartis Investigative Site #3
Ostrava, Czechia
Novartis Investigative Site
Aßlar, Germany
Novartis Investigative Site
Bensheim, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Einbeck, Germany
Novartis Investigative Site #1
Hamburg, Germany
Novartis Investigative Site #2
Hamburg, Germany
Novartis Investigative Site #3
Hamburg, Germany
Novartis Investigative Site #4
Hamburg, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site #1
Kassel, Germany
Novartis Investigative Site #2
Kassel, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Saarlouis, Germany
Novartis Investigative Site
Schliemannstadt Neubukow, Germany
Novartis Investigative Site
Tübingen, Germany
Novartis Investigative Site #1
Guatemala City, Guatemala
Novartis Investigative Site #2
Guatemala City, Guatemala
Novartis Investigative Site #3
Guatemala City, Guatemala
Novartis Investigative Site #4
Guatemala City, Guatemala
Novartis Investigative Site #5
Guatemala City, Guatemala
Novartis Investigative Site #1
Hong Kong, Hong Kong
Novartis Investigative Site #2
Hong Kong, Hong Kong
Novartis Investigative Site #1
Budapest, Hungary
Novartis Investigative Site #2
Budapest, Hungary
Novartis Investigative Site
Dunaújváros, Hungary
Novartis Investigative Site
Nyíregyháza, Hungary
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Indore, India
Novartis Investigative Site
Jaipur, India
Novartis Investigative Site
Karnāl, India
Novartis Investigative Site #2
Mumbai, India
Novartis Investigative Site #1
Mumbia, India
Novartis Investigative Site #1
Nagpur, India
Novartis Investigative Site #2
Nagpur, India
Novartis Investigative Site
Nashik, India
Novartis Investigative Site #1
Trivandrum, India
Novartis Investigative Site #2
Trivandrum, India
Novartis Investigative Site
Alba Iulia, Romania
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site #1
Oradea, Romania
Novartis Investigative Site #2
Oradea, Romania
Novartis Investigative Site
Târgu Mureş, Romania
Novartis Investigative Site
Banská Bystrica, Slovakia
Novartis Investigative Site #1
Bratislava, Slovakia
Novartis Investigative Site #2
Bratislava, Slovakia
Novartis Investigative Site #3
Bratislava, Slovakia
Novartis Investigative Site #1
Košice, Slovakia
Novartis Investigative Site #2
Košice, Slovakia
Novartis Investigative Site
Prešov, Slovakia
Novartis Investigative Site
Štúrovo, Slovakia
Novartis Investigative Site
Carmarthen, United Kingdom
Novartis Investigative Site #1
Glasgow, United Kingdom
Novartis Investigative Site #2
Glasgow, United Kingdom
Related Publications (1)
Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151.
PMID: 23961326RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 23, 2017
Record last verified: 2017-02