VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2019-04-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).

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

Details

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

Criteria

Key Inclusion Criteria:

• Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago

• glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1

• Treatment-naïve.

• Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1

Key Exclusion Criteria:

• Pregnant or nursing (lactating) women

• Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)

• Previous or current participation in any vildagliptin clinical study.

• History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.

• Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.

• Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period.