Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
NCT ID: NCT01758380
Last Updated: 2013-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
557 participants
INTERVENTIONAL
2013-01-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vildagliptin + placebo to Gliclazide
Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
Vildagliptin
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
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)
Gliclazide + placebo to Vildagliptin
Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
Gliclazide
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
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).
Interventions
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Vildagliptin
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
Gliclazide
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
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)
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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 Pharma AG
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Frederiksberg, , Denmark
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Alexandria, , Egypt
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Cairo, , Egypt
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Augsburg, , Germany
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Augsburg, , Germany
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Bad Oeynhausen, , Germany
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Berlin, , Germany
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Dortmund, , Germany
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Einbeck, , Germany
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Löhne, , Germany
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Meine, , Germany
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München, , Germany
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Saarlouis, , Germany
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Malang, East Java, Indonesia
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Surabaya, East Java, Indonesia
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Jakarta, Jakarta Special Capital Region, Indonesia
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Jakarta, Jakarta Special Capital Region, Indonesia
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Padang, West Sumatra, Indonesia
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Amman, Amman Governorate, Jordan
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Kuwait City, Kuwait, Kuwait
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Beirut, , Lebanon
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Beirut, , Lebanon
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Hazmiyeh, , Lebanon
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Saida, , Lebanon
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Kota Bharu, Kelantan, Malaysia
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Kuala Lumpur, , Malaysia
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Krasnodar, , Russia
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Penza, , Russia
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Rostov-on-Don, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Ufa, , Russia
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Dammam, Dammam, Saudi Arabia
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Riyadh, , Saudi Arabia
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Málaga, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Girona, Catalonia, Spain
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Salt, Catalonia, Spain
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Santa Coloma de Gramanet, Catalonia, Spain
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Vic, Catalonia, Spain
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Ceuta, Ceuta, Spain
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Melilla, Melilla, Spain
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Monastir, Tunisia, Tunisia
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Le Belvedere - Tunis, Tunisie, Tunisia
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Sfax, Tunisie, Tunisia
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Tunis, Tunisie, Tunisia
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Sousse, , Tunisia
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Tunis, , Tunisia
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Tunis, , Tunisia
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Diskapi / Ankara, Turkey, Turkey (Türkiye)
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Istanbul, Turkey, Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Dubai, , United Arab Emirates
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Leicester, Leicestershire, United Kingdom
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London, London, United Kingdom
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Bolton, , United Kingdom
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Derby, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
Other Identifiers
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2011-005499-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLAF237A2411
Identifier Type: -
Identifier Source: org_study_id