Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01224366
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
448 participants
INTERVENTIONAL
2010-09-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vildagliptin
Vildagliptin
Placebo
Placebo
Interventions
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Vildagliptin
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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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
Countries
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References
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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.
Other Identifiers
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CLAF237A23135
Identifier Type: -
Identifier Source: org_study_id
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