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Clinical Trial Details

Trial ID: L1847
Source ID: NCT01649466
Associated Drug: Laf237
Title: Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
Acronym: BENEFIT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: LAF237|DRUG: Protaphane
Outcome Measures: Primary: Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain, Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) and weight gain., 24 weeks|Rate of confirmed hypoglycemic events, Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride., 24 weeks | Secondary: Incidence of severe hypoglycemic events, To evaluate the incidence of severe hypoglycemic events (suspected grade 2 and confirmed grade 2 events) in patients treated with vildagliptin versus NPH insulin add-on to glimepiride., 24 weeks|Incidence of symptomatic hypoglycemic events, To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride., 24 weeks|Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event, To evaluate the percentage of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events., 24 weeks|Change from baseline in body weight at 24 weeks, To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride., Baseline, 24 week|Change from baseline in HbA1c at 24 weeks, To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride., Baseline, 24 week|Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week, The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication., Baseline, 24 week
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 162
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2013-10
Results First Posted:
Last Update Posted: 2016-11-17
Locations: Novartis Investigative Site, Anderbeck, 38836, Germany|Novartis Investigative Site, Augsburg, 86150, Germany|Novartis Investigative Site, Bad Kreuznach, 55545, Germany|Novartis Investigative Site, Bad Oeynhausen, 32549, Germany|Novartis Investigative Site, Balingen, 72336, Germany|Novartis Investigative Site, Berlin, 10115, Germany|Novartis Investigative Site, Berlin, 10117, Germany|Novartis Investigative Site, Berlin, 10627, Germany|Novartis Investigative Site, Berlin, 12347, Germany|Novartis Investigative Site, Berlin, 13189, Germany|Novartis Investigative Site, Berlin, 13597, Germany|Novartis Investigative Site, Dortmund, 44137, Germany|Novartis Investigative Site, Dresden, 01099, Germany|Novartis Investigative Site, Dresden, 01309, Germany|Novartis Investigative Site, Einbeck, 37574, Germany|Novartis Investigative Site, Elsterwerda, 04910, Germany|Novartis Investigative Site, Essen, 45219, Germany|Novartis Investigative Site, Essen, 45276, Germany|Novartis Investigative Site, Fulda, 36037, Germany|Novartis Investigative Site, Gelnhausen, 63571, Germany|Novartis Investigative Site, Graben-Neudorf, 76676, Germany|Novartis Investigative Site, Grossheirath-Rossach, 96269, Germany|Novartis Investigative Site, Herne, 44653, Germany|Novartis Investigative Site, Hildesheim, 31139, Germany|Novartis Investigative Site, Kassel, 34125, Germany|Novartis Investigative Site, Kassel, 34127, Germany|Novartis Investigative Site, Kleve, 47533, Germany|Novartis Investigative Site, Koeln, 51069, Germany|Novartis Investigative Site, Lienen, 49536, Germany|Novartis Investigative Site, Loehne, 32584, Germany|Novartis Investigative Site, Lutherstadt Eisleben, 06295, Germany|Novartis Investigative Site, Magdeburg, 39120, Germany|Novartis Investigative Site, Mainz, 55116, Germany|Novartis Investigative Site, Mayen, 56727, Germany|Novartis Investigative Site, Muenchen, 80339, Germany|Novartis Investigative Site, Muenchen, 81373, Germany|Novartis Investigative Site, Mülheim, 45468, Germany|Novartis Investigative Site, Neubukow, 18233, Germany|Novartis Investigative Site, Oschatz, 04758, Germany|Novartis Investigative Site, Potsdam, 14469, Germany|Novartis Investigative Site, Reinfeld, 23858, Germany|Novartis Investigative Site, Saarlouis, 66740, Germany|Novartis Investigative Site, St. Ingbert - Oberwuerzbach, 66386, Germany|Novartis Investigative Site, Straubing, 94315, Germany|Novartis Investigative Site, Stuttgart, 70191, Germany|Novartis Investigative Site, Villingen-Schwenningen, 78054, Germany|Novartis Investigative Site, Wallerfing, 94574, Germany|Novartis Investigative Site, Wangen, 88239, Germany|Novartis Investigative Site, Wedemark, 30900, Germany|Novartis Investigative Site, Weiskirchen, 66709, Germany|Novartis Investigative Site, Wetzlar-Naunheim, 35584, Germany|Novartis Investigative Site, Wurzen, 04808, Germany|Novartis Investigative Site, Würzburg, 97072, Germany
URL: https://clinicaltrials.gov/show/NCT01649466

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details