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Clinical Trial Details

Trial ID: L7381
Source ID: NCT01528254
Associated Drug: Placebo Of Vildagliptin
Title: VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01528254/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Placebo of vildagliptin|DRUG: vildagliptin|DRUG: Metformin
Outcome Measures: Primary: Time to Initial Treatment Failure, Treatment failure was defined as two consecutive scheduled visits with HbA1c \>= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit., Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Secondary: Rate of Loss in Glycemic Control During Period 1, The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit., Visit 5 (Week 26) to End of Period 1|Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2, The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from 26 weeks after the start of Period 2 to the end of Period 2 were included in the analysis, for participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis., From 26 weeks after start of Period 2 to end of Period 2|Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1, Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from Week 26 to the end of Period 1 was included in the analysis. Baseline FPG was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement is missing. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis., Visit 5 (Week 26) to End of Period 1|Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2, Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from 26 weeks after the start of Period 2 to then end of Period 2 was included in the analysis. Only participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3 were included. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis., From 26 weeks after start of Period 2 to end of Period 2|Rate of Loss of Beta Cell Function From Baseline to End of Study, The rate of change of beta cell function was assessed using the slope of AUC of ISR/G over time (years) where AUC of ISR/G is defined as (Area under curve of Insulin secretion rate (derived using c-peptide))/(Area under curve of Glucose), using meal-test data from 0 to 120 minutes. Baseline AUC of ISR/G was derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements were missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively., Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Rate of Change in Insulin Sensitivity From Baseline to End of Study, The rate of change of insulin sensitivity is assessed using the slope of OGIS over time (years) where Oral glucose insulin sensitivity (OGIS) was calculated as a function of glucose and insulin, using meal-test data from 0 to 120 minutes. Baseline OGIS is derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements are missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively., Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Percentage of Participants With Adverse Events, Serious Adverse Events and Death, Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that LAF237 is safe for the treatment of naïve patients with type 2 diabetes mellitus through the monitoring of relevant clinical and laboratory safety parameters., From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 2004
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-03-30
Completion Date: 2019-04-04
Results First Posted: 2020-04-15
Last Update Posted: 2020-09-24
Locations: Novartis Investigative Site, Caba, Buenos Aires, C1056ABJ, Argentina|Novartis Investigative Site, Caba, Buenos Aires, C1425AGC, Argentina|Novartis Investigative Site, San Isidro, Buenos Aires, 1642, Argentina|Novartis Investigative Site, Caba, Capital Federal, C1179AAB, Argentina|Novartis Investigative Site, Buenos Aires, C1120AAC, Argentina|Novartis Investigative Site, Cordoba, X5000AAW, Argentina|Novartis Investigative Site, Corrientes, 3400, Argentina|Novartis Investigative Site, Brookvale, New South Wales, 2100, Australia|Novartis Investigative Site, Woy Woy, New South Wales, 2256, Australia|Novartis Investigative Site, Morayfield, Queensland, 4506, Australia|Novartis Investigative Site, Wien, A-1130, Austria|Novartis Investigative Site, Fortaleza, CE, 60170-320, Brazil|Novartis Investigative Site, Fortaleza, CE, 60430-350, Brazil|Novartis Investigative Site, Brasilia, DF, 71625-009, Brazil|Novartis Investigative Site, Goiania, GO, 74935-530, Brazil|Novartis Investigative Site, Belem, PA, 66073-000, Brazil|Novartis Investigative Site, Curitiba, PR, 80810-040, Brazil|Novartis Investigative Site, Porto Alegre, RS, 90430 001, Brazil|Novartis Investigative Site, Mogi das Cruzes, SP, 08780-090, Brazil|Novartis Investigative Site, Sao Paulo, SP, 04023-900, Brazil|Novartis Investigative Site, Sao Paulo, SP, 05403 000, Brazil|Novartis Investigative Site, São Paulo, SP, 01224-000, Brazil|Novartis Investigative Site, São Paulo, SP, 01244-030, Brazil|Novartis Investigative Site, Gabrovo, 5300, Bulgaria|Novartis Investigative Site, Kazanlak, 6100, Bulgaria|Novartis Investigative Site, Plovdiv, 4002, Bulgaria|Novartis Investigative Site, Razgrad, Bulgaria|Novartis Investigative Site, Ruse, 7200, Bulgaria|Novartis Investigative Site, Smolian, 4700, Bulgaria|Novartis Investigative Site, Sofia, 1431, Bulgaria|Novartis Investigative Site, Sofia, 1606, Bulgaria|Novartis Investigative Site, Sofia, Bulgaria|Novartis Investigative Site, Cartagena, Bolivar, Colombia|Novartis Investigative Site, Bogota, Cundinamarca, 110221, Colombia|Novartis Investigative Site, Baranquilla, Colombia|Novartis Investigative Site, Bogotá, Colombia|Novartis Investigative Site, Pisek, Czech Republic, 397 01, Czechia|Novartis Investigative Site, Prague 5, Czech Republic, 150 30, Czechia|Novartis Investigative Site, Brandys Nad Labem, 250 01, Czechia|Novartis Investigative Site, Praha, 149 01, Czechia|Novartis Investigative Site, Santo Domingo, Republica Dominicana, Dominican Republic|Novartis Investigative Site, Santo Domingo, Dominican Republic|Novartis Investigative Site, Saku, 75501, Estonia|Novartis Investigative Site, Tallinn, 10117, Estonia|Novartis Investigative Site, Tallinn, 11315, Estonia|Novartis Investigative Site, Tallinn, 11911, Estonia|Novartis Investigative Site, Tallinn, 13415, Estonia|Novartis Investigative Site, Lahti, Suomi, 15110, Finland|Novartis Investigative Site, Kerava, 04200, Finland|Novartis Investigative Site, Kouvola, 45100, Finland|Novartis Investigative Site, Tampere, 33100, Finland|Novartis Investigative Site, Hainstadt, Hainburg, 63512, Germany|Novartis Investigative Site, Aschaffenburg, 63739, Germany|Novartis Investigative Site, Dresden, 01307, Germany|Novartis Investigative Site, Duesseldorf, 40225, Germany|Novartis Investigative Site, Essen, 45276, Germany|Novartis Investigative Site, Essen, 45329, Germany|Novartis Investigative Site, Esslingen am Neckar, 73728, Germany|Novartis Investigative Site, Fulda, 36037, Germany|Novartis Investigative Site, Gelnhausen, 63571, Germany|Novartis Investigative Site, Kamp-Lintfort, 47475, Germany|Novartis Investigative Site, Koeln, 51069, Germany|Novartis Investigative Site, Ludwigshafen, 67059, Germany|Novartis Investigative Site, Neuwied, 56564, Germany|Novartis Investigative Site, Saint Ingbert - Oberwuerzbach, 66386, Germany|Novartis Investigative Site, Wangen, 88239, Germany|Novartis Investigative Site, Clinica, 605, Guatemala|Novartis Investigative Site, Guatemala City, 010014, Guatemala|Novartis Investigative Site, Guatemala City, 01010, Guatemala|Novartis Investigative Site, Hong Kong, Hong Kong|Novartis Investigative Site, HongKong, Hong Kong|Novartis Investigative Site, Zalaegerszeg, Zala, 8900, Hungary|Novartis Investigative Site, Budapest, 1042, Hungary|Novartis Investigative Site, Budapest, 1212, Hungary|Novartis Investigative Site, Csongrad, 6640, Hungary|Novartis Investigative Site, Eger, H-3300, Hungary|Novartis Investigative Site, Kalocsa, 6300, Hungary|Novartis Investigative Site, Szeged, H 6725, Hungary|Novartis Investigative Site, Veszprem, H 8200, Hungary|Novartis Investigative Site, New Delhi, Delhi, 110076, India|Novartis Investigative Site, Bangalore, Karnataka, 560003, India|Novartis Investigative Site, Bangalore, Karnataka, 560034, India|Novartis Investigative Site, Bangalore, Karnataka, 560043, India|Novartis Investigative Site, Kochi, Kerala, 682 041, India|Novartis Investigative Site, Indore, Madhya Pradesh, 452010, India|Novartis Investigative Site, Pune, Maharashtra, 411004, India|Novartis Investigative Site, Pune, Maharashtra, 411011, India|Novartis Investigative Site, Jaipur, Rajasthan, 302015, India|Novartis Investigative Site, Jaipur, Rajasthan, 302023, India|Novartis Investigative Site, Chennai, Tamil Nadu, 600 086, India|Novartis Investigative Site, Chennai, Tamilnadu, 600008, India|Novartis Investigative Site, Chandigarh, 160 012, India|Novartis Investigative Site, Heifa, Israel|Novartis Investigative Site, Jerusalem, 91192, Israel|Novartis Investigative Site, Kfar Saba, 4428164, Israel|Novartis Investigative Site, Rehovot, 7610001, Israel|Novartis Investigative Site, Sefad, 13100, Israel|Novartis Investigative Site, Tel Aviv, 6209804, Israel|Novartis Investigative Site, Tel Giborim, Holon, 58100, Israel|Novartis Investigative Site, Montichiari, BS, 25018, Italy|Novartis Investigative Site, Campobasso, CB, 86100, Italy|Novartis Investigative Site, Arenzano, GE, 16011, Italy|Novartis Investigative Site, Milano, MI, 20100, Italy|Novartis Investigative Site, Milano, MI, 20132, Italy|Novartis Investigative Site, Casorate Primo, PV, 27022, Italy|Novartis Investigative Site, Roma, RM, 00133, Italy|Novartis Investigative Site, Roma, RM, 00161, Italy|Novartis Investigative Site, Incheon, Gyeonggi-do, 21431, Korea, Republic of|Novartis Investigative Site, Suwon, Gyeonggi-do, 442-723, Korea, Republic of|Novartis Investigative Site, Uijeongbu-Si, Gyeonggi-do, 480-717, Korea, Republic of|Novartis Investigative Site, Seoul, Korea, 03312, Korea, Republic of|Novartis Investigative Site, Seoul, Seocho Gu, 06591, Korea, Republic of|Novartis Investigative Site, Daejeon, 301-804, Korea, Republic of|Novartis Investigative Site, Incheon, 403-720, Korea, Republic of|Novartis Investigative Site, Seoul, 150-713, Korea, Republic of|Novartis Investigative Site, Jelgava, LV, 3001, Latvia|Novartis Investigative Site, Liepaja, LV, 3401, Latvia|Novartis Investigative Site, Ogre, LV, 5001, Latvia|Novartis Investigative Site, Riga, LV, 1002, Latvia|Novartis Investigative Site, Riga, LV, 1011, Latvia|Novartis Investigative Site, Talsi, LV, 3201, Latvia|Novartis Investigative Site, Daugavpils, LV-5417, Latvia|Novartis Investigative Site, Riga, 1057, Latvia|Novartis Investigative Site, Riga, LV 1002, Latvia|Novartis Investigative Site, Kaunas, LTU, LT 50161, Lithuania|Novartis Investigative Site, Vilnius, LT, Lithuania|Novartis Investigative Site, Jonava, 55268, Lithuania|Novartis Investigative Site, Kaunas, 48259, Lithuania|Novartis Investigative Site, Kaunas, 51270, Lithuania|Novartis Investigative Site, Vilnius, LT-08661, Lithuania|Novartis Investigative Site, Kota Bahru, Kelantan, 16150, Malaysia|Novartis Investigative Site, Kuala Lumpur, 56000, Malaysia|Novartis Investigative Site, Kuala Lumpur, 59100, Malaysia|Novartis Investigative Site, Ciudad De Mexico, Distrito Federal, 11850, Mexico|Novartis Investigative Site, Mexico D.F, Distrito Federal, 03100, Mexico|Novartis Investigative Site, México, Distrito Federal, 03800, Mexico|Novartis Investigative Site, Cuautla, Morelos, 62746, Mexico|Novartis Investigative Site, Cuernavaca, Morelos, 62250, Mexico|Novartis Investigative Site, Aguascalientes, 20230, Mexico|Novartis Investigative Site, Distrito Federal, 14000, Mexico|Novartis Investigative Site, Durango, 34000, Mexico|Novartis Investigative Site, Querétaro, 76000, Mexico|Novartis Investigative Site, Enebakk, 1912, Norway|Novartis Investigative Site, Fetsund, 1900, Norway|Novartis Investigative Site, Honefoss, 3515, Norway|Novartis Investigative Site, Oslo, 0424, Norway|Novartis Investigative Site, Spikkestad, 3430, Norway|Novartis Investigative Site, Panama City, 0834-01862, Panama|Novartis Investigative Site, Panama City, Panama|Novartis Investigative Site, Trujillo, La Libertad, Peru|Novartis Investigative Site, Cercado De Lima, Lima, 01, Peru|Novartis Investigative Site, Chorrillos, Lima, 09, Peru|Novartis Investigative Site, Magdalena, Lima, 17, Peru|Novartis Investigative Site, San Isidro, Lima, 27, Peru|Novartis Investigative Site, San Martin de Porres, Lima, 31, Peru|Novartis Investigative Site, Arequipa, Peru|Novartis Investigative Site, Marikina, Metro Manila, 1810, Philippines|Novartis Investigative Site, Quezon City, Metro Manila, 1109, Philippines|Novartis Investigative Site, Marikina City, 1800, Philippines|Novartis Investigative Site, Pasay City, 1300, Philippines|Novartis Investigative Site, Pasig City, 1600, Philippines|Novartis Investigative Site, San Juan City, 1500, Philippines|Novartis Investigative Site, Poznan, 60-821, Poland|Novartis Investigative Site, Poznan, 61-251, Poland|Novartis Investigative Site, Poznan, 61-655, Poland|Novartis Investigative Site, Wroclaw, 50-349, Poland|Novartis Investigative Site, Zabrze, 41-800, Poland|Novartis Investigative Site, Oradea, Bihor, 410001, Romania|Novartis Investigative Site, Oradea, Jud. Bihor, 410619, Romania|Novartis Investigative Site, Ploiesti, Jud. Prahova, 100097, Romania|Novartis Investigative Site, Bucharest, 020045, Romania|Novartis Investigative Site, Bucharest, 020475, Romania|Novartis Investigative Site, Bucuresti, Romania|Novartis Investigative Site, Timisoara, Romania|Novartis Investigative Site, Moscow, 101990, Russian Federation|Novartis Investigative Site, N.Novgorod, 603126, Russian Federation|Novartis Investigative Site, Penza, 440026, Russian Federation|Novartis Investigative Site, Petrozavodsk, 185019, Russian Federation|Novartis Investigative Site, Ryazan, 390026, Russian Federation|Novartis Investigative Site, Saint Petersburg, 194044, Russian Federation|Novartis Investigative Site, Saint Petersburg, 198260, Russian Federation|Novartis Investigative Site, Saratov, 410012, Russian Federation|Novartis Investigative Site, Smolensk, 214019, Russian Federation|Novartis Investigative Site, St-Petersburg, 194358, Russian Federation|Novartis Investigative Site, St.- Petersburg, 199034, Russian Federation|Novartis Investigative Site, Bratislava, Slovak Republic, 85101, Slovakia|Novartis Investigative Site, Kosice, Slovak Republic, 04001, Slovakia|Novartis Investigative Site, Lucenec, Slovak Republic, 98401, Slovakia|Novartis Investigative Site, Namestovo, Slovak Republic, 02901, Slovakia|Novartis Investigative Site, Roznava, Slovak Republic, 04801, Slovakia|Novartis Investigative Site, Sala, Slovak Republic, 92701, Slovakia|Novartis Investigative Site, Trebisov, Slovak Republic, 075 01, Slovakia|Novartis Investigative Site, Zilina, Slovak Republic, 010 01, Slovakia|Novartis Investigative Site, Banska Bystrica, 974 01, Slovakia|Novartis Investigative Site, Kosice, 040 01, Slovakia|Novartis Investigative Site, Kosice, 040 22, Slovakia|Novartis Investigative Site, Levice, 934 01, Slovakia|Novartis Investigative Site, Nové Zámky, 940 01, Slovakia|Novartis Investigative Site, Presov, 080 01, Slovakia|Novartis Investigative Site, Sabinov, 08301, Slovakia|Novartis Investigative Site, Sered, 92601, Slovakia|Novartis Investigative Site, Sturovo, 94301, Slovakia|Novartis Investigative Site, Zilina, 012 07, Slovakia|Novartis Investigative Site, Alberton, 1449, South Africa|Novartis Investigative Site, Cape Town, 7925, South Africa|Novartis Investigative Site, Durban, 4030, South Africa|Novartis Investigative Site, Durban, 4126, South Africa|Novartis Investigative Site, Gauteng, South Africa|Novartis Investigative Site, Johannesburg, 1820, South Africa|Novartis Investigative Site, Johannesburg, 2188, South Africa|Novartis Investigative Site, Pretoria, 0184, South Africa|Novartis Investigative Site, Pretoria, 1022, South Africa|Novartis Investigative Site, Sant Adria Del Besos, Barcelona, 08930, Spain|Novartis Investigative Site, Santa Coloma De Gramanet, Barcelona, 08921, Spain|Novartis Investigative Site, Barcelona, Cataluña, 08025, Spain|Novartis Investigative Site, Barcelona, 08020, Spain|Novartis Investigative Site, Hsintien, 231, Taiwan|Novartis Investigative Site, Taichung, 40705, Taiwan|Novartis Investigative Site, Taipei, 114, Taiwan|Novartis Investigative Site, Taoyuan, 33305, Taiwan|Novartis Investigative Site, Adana, 01330, Turkey|Novartis Investigative Site, Antalya, 07070, Turkey|Novartis Investigative Site, Denizli, 20070, Turkey|Novartis Investigative Site, Diskapi / Ankara, 06770, Turkey|Novartis Investigative Site, Istanbul, 34093, Turkey|Novartis Investigative Site, Izmir, 35040, Turkey|Novartis Investigative Site, Izmir, 35340, Turkey|Novartis Investigative Site, Kahramanmaras, 46100, Turkey
URL: https://clinicaltrials.gov/show/NCT01528254

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details
D089 Metformin small molecule DB00331 Details