Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride (Vildagliptin)

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233622

CLAF237A23152

EudraCT 2010-021097-11

Details and patient eligibility

About

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Enrollment: 317 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Confirmed diagnosis of T2DM by standard criteria.
• Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
• Age: ≥18 to ≤ 80 years
• HbA1c of ≥ 7.5 and ≤ 11.0%
• Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

• FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
• Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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317 participants in 2 patient groups, including a placebo group

Vildagliptin (metformin + glimepiride)

Experimental group

Treatment:

Drug: Vildagliptin

Placebo (metformin + glimepiride)

Placebo Comparator group

Treatment:

Drug: Placebo