Clinical trial NCT01224366: Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Add-on to insulin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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/exclusion criteria may apply

Primary outcomes:
measure: HbA1c reduction
timeFrame: 24 weeks
Secondary outcomes:
measure: HbA1c reduction in subpopulation treated with insulin and with metformin
timeFrame: 24 weeks
measure: HbA1c reduction in subpopulation treated with insulin and without metformin
timeFrame: 24 weeks
measure: Reduction in FPG (overall and subpopulations)
timeFrame: 24 weeks
measure: Responder rates (overall and subpopulations)
timeFrame: 24 weeks
measure: Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Novartis Investigative Site
city: Heidelberg Heights
country: Australia
facility: Novartis Investigative Site
city: Parkville
country: Australia
facility: Novartis Investigative Site
city: Wollongong
country: Australia
facility: Novartis Investigative Site #1
city: Wollongong
country: Australia
facility: Novartis Investigative Site #2
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: La Louviere
country: Belgium
facility: Novartis Investigative Site
city: Ronse
country: Belgium
facility: Novartis Investigative Site
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site #1
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site #2
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site #3
city: Asslar
country: Germany
facility: Novartis Investigative Site
city: Bensheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Einbeck
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site #1
city: Hamburg
country: Germany
facility: Novartis Investigative Site #2
city: Hamburg
country: Germany
facility: Novartis Investigative Site #3
city: Hamburg
country: Germany
facility: Novartis Investigative Site #4
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site #1
city: Kassel
country: Germany
facility: Novartis Investigative Site #2
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Neubukow
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site #1
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site #2
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site #3
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site #4
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site #5
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site #1
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site #2
city: Budapest
country: Hungary
facility: Novartis Investigative Site #1
city: Budapest
country: Hungary
facility: Novartis Investigative Site #2
city: Dunaujvaros
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Indore
country: India
facility: Novartis Investigative Site
city: Jaipur
country: India
facility: Novartis Investigative Site
city: Karnal
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site #2
city: Mumbia
country: India
facility: Novartis Investigative Site #1
city: Nagpur
country: India
facility: Novartis Investigative Site #1
city: Nagpur
country: India
facility: Novartis Investigative Site #2
city: Nasik
country: India
facility: Novartis Investigative Site
city: Trivandrum
country: India
facility: Novartis Investigative Site #1
city: Trivandrum
country: India
facility: Novartis Investigative Site #2
city: Alba-Iulia
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Oradea
country: Romania
facility: Novartis Investigative Site #1
city: Oradea
country: Romania
facility: Novartis Investigative Site #2
city: Targu-Mures
country: Romania
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site #1
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site #2
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site #3
city: Kosice
country: Slovakia
facility: Novartis Investigative Site #1
city: Kosice
country: Slovakia
facility: Novartis Investigative Site #2
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Sturovo
country: Slovakia
facility: Novartis Investigative Site
city: Carmarthen
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site #1
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site #2
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.