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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Gliclazide; Metformin; Vildagliptin

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"