Clinical trial NCT01233622: Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Official title: A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 317
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: This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).


Eligibility criteria: Inclusion criteria

* Confirmed diagnosis of T2DM by standard criteria.
* Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
* Age: ≥18 to ≤ 80 years
* HbA1c of ≥ 7.5 and ≤ 11.0%
* Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: HbA1c Reduction
timeFrame: 24 weeks
Secondary outcomes:
measure: FPG reduction
timeFrame: 24 weeks
measure: Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
timeFrame: 24 weeks
measure: Responder Rate
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Novartis Investigative Site
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
city: Parkville
country: Australia
facility: Novartis Investigative Site
city: St. Leonards
country: Australia
facility: Novartis Investigative Site
city: Anderbeck
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site #1
city: Berlin
country: Germany
facility: Novartis Investigative Site #2
city: Berlin
country: Germany
facility: Novartis Investigative Site #3
city: Berlin
country: Germany
facility: Novartis Investigative Site #4
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Sangerhausen
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Bergamo
country: Italy
facility: Novartis Investigative Site
city: Cosenza
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site #1
city: Roma
country: Italy
facility: Novartis Investigative Site #2
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Bundang
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site #1
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site #2
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site #3
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site #1
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site #2
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site #3
city: Durango
country: Mexico
facility: Novartis Investigative Site #1
city: Durango
country: Mexico
facility: Novartis Investigative Site #2
city: Durango
country: Mexico
facility: Novartis Investigative Site #3
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site #1
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site #2
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site #3
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site #4
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site #5
city: Mexico
country: Mexico
facility: Novartis Investigative Site
city: Pachuca
country: Mexico
facility: Novartis Investigative Site #1
city: Pachuca
country: Mexico
facility: Novartis Investigative Site #2
city: Pachuca
country: Mexico
facility: Novartis Investigative Site #3
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site #1
city: Quezon City
country: Philippines
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: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Yongkang
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.