Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan (STEADFAST)

• Proportion 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 ]
• Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) to test non-inferiority [ 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

• Proportion 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) to test superiority (provided the 2 primary objectives are met) [ 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 ]

To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.

• Drug: Vildagliptin
  Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
  Other Name: Galvus
• Drug: 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).

• 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.
  Interventions:

  • Drug: Vildagliptin
  • Drug: Metformin
  • Drug: Placebo to Gliclazide
• 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.
  Interventions:

  • Drug: Gliclazide
  • Drug: Metformin
  • Drug: Placebo to Vildagliptin

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"