Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of T2DM by standard criteria.

• HbA1c ≥ 7.0 to ≤ 10% at Visit 1.

• Age: ≥ 20 to < 75 years old at Visit 1.

• BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion Criteria:

• FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.

• Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.

• Significant heart diseases

• Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply