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Clinical Trial Details

Trial ID: L2524
Source ID: NCT01758380
Associated Drug: Vildagliptin
Title: Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Acronym: STEADFAST
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Vildagliptin|DRUG: Gliclazide|DRUG: Metformin|DRUG: Placebo to Gliclazide|DRUG: Placebo to Vildagliptin
Outcome Measures: Primary: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority, 1 month | Secondary: Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs), visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs|Change from baseline to endpoint in glycosylated hemoglobin (HbA1c), Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication, baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)|Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c), Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication, visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)|Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period, 1 month|mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day, assessed in a selected subgroup of patients, 72 hours|Treatment adherence during the Ramadan fasting period, 1 month|Change from visit 3 (pre-Ramadan visit) to endpoint in body weight, Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication, From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)|Number of unscheduled visit to health care professional, From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)|Number of days fasted during the Ramadan fasting period, 1 month|Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability, Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 557
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-01
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2013-10-17
Locations: Novartis Investigative Site, Frederiksberg, 1819, Denmark|Novartis Investigative Site, Alexandria, 21131, Egypt|Novartis Investigative Site, Cairo, 11566, Egypt|Novartis Investigative Site, Augsburg, 86150, Germany|Novartis Investigative Site, Augsburg, 86159, Germany|Novartis Investigative Site, Bad Oeynhausen, 32549, Germany|Novartis Investigative Site, Berlin, 10997, Germany|Novartis Investigative Site, Dortmund, 44137, Germany|Novartis Investigative Site, Einbeck, 37574, Germany|Novartis Investigative Site, Loehne, 32584, Germany|Novartis Investigative Site, Meine, 38527, Germany|Novartis Investigative Site, München, 80339, Germany|Novartis Investigative Site, Saarlouis, 66740, Germany|Novartis Investigative Site, Malang, East Java, 65111, Indonesia|Novartis Investigative Site, Surabaya, East Java, 60286, Indonesia|Novartis Investigative Site, Padang, Sumatera Barat, 25127, Indonesia|Novartis Investigative Site, Jakarta, 10220, Indonesia|Novartis Investigative Site, Jakarta, 10430, Indonesia|Novartis Investigative Site, Amman, 11196, Jordan|Novartis Investigative Site, Kuwait, 1180, Kuwait|Novartis Investigative Site, Beirut, 1107 2020, Lebanon|Novartis Investigative Site, Beirut, Lebanon|Novartis Investigative Site, Hazmieh, 470, Lebanon|Novartis Investigative Site, Saida, Lebanon|Novartis Investigative Site, Kota Bahru, Kelantan, 16150, Malaysia|Novartis Investigative Site, Kuala Lumpur, 59100, Malaysia|Novartis Investigative Site, Krasnodar, 350063, Russian Federation|Novartis Investigative Site, Penza, 440026, Russian Federation|Novartis Investigative Site, Rostov on Don, 344000, Russian Federation|Novartis Investigative Site, Rostov-on-Don, 344718, Russian Federation|Novartis Investigative Site, Saratov, 410012, Russian Federation|Novartis Investigative Site, St. Petersburg, 191015, Russian Federation|Novartis Investigative Site, St.- Petersburg, 199034, Russian Federation|Novartis Investigative Site, Ufa, 450000, Russian Federation|Novartis Investigative Site, Dammam, 40145, Saudi Arabia|Novartis Investigative Site, Riyadh, 11426, Saudi Arabia|Novartis Investigative Site, Singapore, 440080, Singapore|Novartis Investigative Site, Singapore, 545025, Singapore|Novartis Investigative Site, Singapore, 659164, Singapore|Novartis Investigative Site, Málaga, Andalucia, 29010, Spain|Novartis Investigative Site, Barcelona, Cataluña, 08001, Spain|Novartis Investigative Site, Girona, Cataluña, 17007, Spain|Novartis Investigative Site, Salt, Cataluña, 17190, Spain|Novartis Investigative Site, Santa Coloma de Gramanet, Cataluña, 08923, Spain|Novartis Investigative Site, Vic, Cataluña, 08500, Spain|Novartis Investigative Site, Ceuta, 51002, Spain|Novartis Investigative Site, Melilla, 52005, Spain|Novartis Investigative Site, Le Belvedere - Tunis, Tunisie, 1002, Tunisia|Novartis Investigative Site, Sfax, Tunisie, 3029, Tunisia|Novartis Investigative Site, Tunis, Tunisie, 1007, Tunisia|Novartis Investigative Site, Monastir, 5000, Tunisia|Novartis Investigative Site, Sousse, 4000, Tunisia|Novartis Investigative Site, Tunis, 1007, Tunisia|Novartis Investigative Site, Tunis, Tunisia|Novartis Investigative Site, Diskapi / Ankara, 06770, Turkey|Novartis Investigative Site, Istanbul, 34093, Turkey|Novartis Investigative Site, Istanbul, 34304, Turkey|Novartis Investigative Site, Izmir, 35380, Turkey|Novartis Investigative Site, Kahramanmaras, 46050, Turkey|Novartis Investigative Site, Dubai, United Arab Emirates|Novartis Investigative Site, Leicester, Leicestershire, LE5 4PW, United Kingdom|Novartis Investigative Site, Birmingham, B15 2TT, United Kingdom|Novartis Investigative Site, Birmingham, B8 3Sw, United Kingdom|Novartis Investigative Site, Birmingham, B9 5SS, United Kingdom|Novartis Investigative Site, Bolton, BL4 0JR, United Kingdom|Novartis Investigative Site, Derby, DE22 3NE, United Kingdom|Novartis Investigative Site, London, W6 7HY, United Kingdom|Novartis Investigative Site, Manchester, M13 9WL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01758380

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details
D333 Gliclazide small molecule DB01120 Details
D089 Metformin small molecule DB00331 Details