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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Placebo to Vildagliptin; Drug: Gliclazide; Drug: Vildagliptin; Drug: Placebo to Gliclazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01758380

2011-005499-41 (EudraCT Number)

CLAF237A2411

Details and patient eligibility

About

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

Enrollment: 557 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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557 participants in 2 patient groups

Vildagliptin + placebo to Gliclazide

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Drug: Placebo to Gliclazide

Drug: Vildagliptin

Gliclazide + placebo to Vildagliptin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin

Drug: Placebo to Vildagliptin

Drug: Gliclazide