Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Overview[ - collapse ][ - ]
Purpose | To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Vildagliptin Drug: Gliclazide Drug: Metformin Drug: Placebo to Gliclazide Drug: Placebo to Vildagliptin |
Phase | Phase 4 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT01758380 |
First Received | December 24, 2012 |
Last Updated | October 16, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 24, 2012 |
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Last Updated Date | October 16, 2013 |
Start Date | January 2013 |
Estimated Primary Completion Date | September 2013 |
Current Primary Outcome Measures | Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority [Time Frame: 1 month] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan |
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Official Title | A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan |
Brief Summary | To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Vildagliptin Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy) Other Names: GalvusDrug: Gliclazide Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) Drug: Metformin Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion Drug: Placebo to Gliclazide Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) Drug: Placebo to Vildagliptin Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy). |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 557 |
Estimated Completion Date | September 2013 |
Estimated Primary Completion Date | September 2013 |
Eligibility Criteria | Inclusion Criteria: - Confirmed Type 2 Diabetes diagnosis - Plan to fast during Ramadan - Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1 - Taking a sulfonylurea treatment for less than 3 years prior to Visit 1 - Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1 Exclusion Criteria: - Pregnant or nursing (lactating) women - History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. - Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component. - Inability to comply with the study procedures or medications. "Other protocol-defined inclusion/exclusion criteria may apply" |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Denmark, Egypt, Germany, India, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Tunisia, Turkey, United Arab Emirates, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01758380 |
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Other Study ID Numbers | CLAF237A2411 |
Has Data Monitoring Committee | No |
Information Provided By | Novartis |
Study Sponsor | Novartis Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharma AG Novartis Pharmaceuticals |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Novartis Investigative Site | Frederiksberg, Denmark, 1819 |
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Novartis Investigative Site | Alexandria, Egypt, 21131 |
Novartis Investigative Site | Cairo, Egypt, 11566 |
Novartis Investigative Site | Augsburg, Germany, 86150 |
Novartis Investigative Site | Augsburg, Germany, 86159 |
Novartis Investigative Site | Bad Oeynhausen, Germany, 32549 |
Novartis Investigative Site | Berlin, Germany, 10997 |
Novartis Investigative Site | Dortmund, Germany, 44137 |
Novartis Investigative Site | Einbeck, Germany, 37574 |
Novartis Investigative Site | Loehne, Germany, 32584 |
Novartis Investigative Site | Meine, Germany, 38527 |
Novartis Investigative Site | München, Germany, 80339 |
Novartis Investigative Site | Saarlouis, Germany, 66740 |
Novartis Investigative Site | Malang, East Java, Indonesia, 65111 |
Novartis Investigative Site | Surabaya, East Java, Indonesia, 60286 |
Novartis Investigative Site | Padang, Sumatera Barat, Indonesia, 25127 |
Novartis Investigative Site | Jakarta, Indonesia, 10430 |
Novartis Investigative Site | Jakarta, Indonesia, 10220 |
Novartis Investigative Site | Amman, Jordan, 11196 |
Novartis Investigative Site | Kuwait, Kuwait, 1180 |
Novartis Investigative Site | Beirut, Lebanon |
Novartis Investigative Site | Beirut, Lebanon, 1107 2020 |
Novartis Investigative Site | Hazmieh, Lebanon, 470 |
Novartis Investigative Site | Saida, Lebanon |
Novartis Investigative Site | Kota Bahru, Kelantan, Malaysia, 16150 |
Novartis Investigative Site | Kuala Lumpur, Malaysia, 59100 |
Novartis Investigative Site | Krasnodar, Russian Federation, 350063 |
Novartis Investigative Site | Penza, Russian Federation, 440026 |
Novartis Investigative Site | Rostov on Don, Russian Federation, 344000 |
Novartis Investigative Site | Rostov-on-Don, Russian Federation, 344718 |
Novartis Investigative Site | Saratov, Russian Federation, 410012 |
Novartis Investigative Site | St. Petersburg, Russian Federation, 191015 |
Novartis Investigative Site | St.- Petersburg, Russian Federation, 199034 |
Novartis Investigative Site | Ufa, Russian Federation, 450000 |
Novartis Investigative Site | Dammam, Saudi Arabia, 40145 |
Novartis Investigative Site | Riyadh, Saudi Arabia, 11426 |
Novartis Investigative Site | Singapore, Singapore, 545025 |
Novartis Investigative Site | Singapore, Singapore, 440080 |
Novartis Investigative Site | Singapore, Singapore, 659164 |
Novartis Investigative Site | Málaga, Andalucia, Spain, 29010 |
Novartis Investigative Site | Barcelona, Cataluña, Spain, 08001 |
Novartis Investigative Site | Girona, Cataluña, Spain, 17007 |
Novartis Investigative Site | Salt, Cataluña, Spain, 17190 |
Novartis Investigative Site | Santa Coloma de Gramanet, Cataluña, Spain, 08923 |
Novartis Investigative Site | Vic, Cataluña, Spain, 08500 |
Novartis Investigative Site | Ceuta, Spain, 51002 |
Novartis Investigative Site | Melilla, Spain, 52005 |
Novartis Investigative Site | Le Belvedere - Tunis, Tunisie, Tunisia, 1002 |
Novartis Investigative Site | Sfax, Tunisie, Tunisia, 3029 |
Novartis Investigative Site | Tunis, Tunisie, Tunisia, 1007 |
Novartis Investigative Site | Monastir, Tunisia, 5000 |
Novartis Investigative Site | Sousse, Tunisia, 4000 |
Novartis Investigative Site | Tunis, Tunisia |
Novartis Investigative Site | Tunis, Tunisia, 1007 |
Novartis Investigative Site | Diskapi / Ankara, Turkey, 06770 |
Novartis Investigative Site | Istanbul, Turkey, 34093 |
Novartis Investigative Site | Istanbul, Turkey, 34304 |
Novartis Investigative Site | Izmir, Turkey, 35380 |
Novartis Investigative Site | Kahramanmaras, Turkey, 46050 |
Novartis Investigative Site | Dubai, United Arab Emirates |
Novartis Investigative Site | Leicester, Leicestershire, United Kingdom, LE5 4PW |
Novartis Investigative Site | Birmingham, United Kingdom, B15 2TT |
Novartis Investigative Site | Birmingham, United Kingdom, B8 3Sw |
Novartis Investigative Site | Birmingham, United Kingdom, B9 5SS |
Novartis Investigative Site | Bolton, United Kingdom, BL4 0JR |
Novartis Investigative Site | Derby, United Kingdom, DE22 3NE |
Novartis Investigative Site | London, United Kingdom, W6 7HY |
Novartis Investigative Site | Manchester, United Kingdom, M13 9WL |