Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
NCT ID: NCT01871558
Last Updated: 2016-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2013-06-30
2015-02-28
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
NONE
Study Groups
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SU+metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Metformin
metformin is to be kept unchanged
sulfonylurea (SU)
Basal Insulin
Metformin/vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Vildagliptin
50 mg b.i.d
Metformin
metformin is to be kept unchanged
Basal Insulin
Interventions
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Vildagliptin
50 mg b.i.d
Metformin
metformin is to be kept unchanged
sulfonylurea (SU)
Basal Insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
* with a glycemic target of HbA1c \<= 7%
* with HbA1c at inclusion \>7% and \<=9%
* Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)
Exclusion Criteria
* acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Antibes, , France
Novartis Investigative Site
Auxerre, , France
Novartis Investigative Site
Bar-le-Duc, , France
Novartis Investigative Site
Bondy, , France
Novartis Investigative Site
Brest, , France
Novartis Investigative Site
Caen, , France
Novartis Investigative Site
Corbeil-Essonnes, , France
Novartis Investigative Site
Fleury-sur-Orne, , France
Novartis Investigative Site
Maisons-Laffitte, , France
Novartis Investigative Site
Menton, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Saint-Nazaire, , France
Novartis Investigative Site
Sanary-sur-Mer, , France
Novartis Investigative Site
Strsbourg, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Valence, , France
Novartis Investigative Site
Valenciennes, , France
Countries
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Other Identifiers
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CLAF237AFR07
Identifier Type: -
Identifier Source: org_study_id
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