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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Vildagliptin
Drug: Gliclazide
Drug: Metformin
Drug: Placebo to Gliclazide
Drug: Placebo to Vildagliptin
PhasePhase 4
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT01758380
First ReceivedDecember 24, 2012
Last UpdatedOctober 16, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateDecember 24, 2012
Last Updated DateOctober 16, 2013
Start DateJanuary 2013
Estimated Primary Completion DateSeptember 2013
Current Primary Outcome MeasuresPercentage 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
  • Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs) [Time Frame: 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] [Designated as safety issue: No]
  • Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) [Time Frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)] [Designated as safety issue: No]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
  • Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) [Time Frame: 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)] [Designated as safety issue: No]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
  • Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period [Time Frame: 1 month] [Designated as safety issue: Yes]
  • mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [Time Frame: 72 hours] [Designated as safety issue: No]assessed in a selected subgroup of patients
  • Treatment adherence during the Ramadan fasting period [Time Frame: 1 month] [Designated as safety issue: No]
  • Change from visit 3 (pre-Ramadan visit) to endpoint in body weight [Time Frame: 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)] [Designated as safety issue: No]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
  • Number of unscheduled visit to health care professional [Time Frame: 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)] [Designated as safety issue: No]
  • Number of days fasted during the Ramadan fasting period [Time Frame: 1 month] [Designated as safety issue: No]
  • 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 [Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleVildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: 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)
  • Experimental: 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.
  • Active Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment557
Estimated Completion DateSeptember 2013
Estimated Primary Completion DateSeptember 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"
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesDenmark, 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
Other Study ID NumbersCLAF237A2411
Has Data Monitoring CommitteeNo
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharma AG Novartis Pharmaceuticals
Verification DateOctober 2013

Locations[ + expand ][ + ]

Novartis Investigative Site
Frederiksberg, Denmark, 1819
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