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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Placebo; Drug: Metformin; Drug: Vildagliptin (LAF237); Drug: Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02002221

CLAF237A1405

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

156 participants in 2 patient groups, including a placebo group

Vildagliptin (LAF237)

Experimental group

Description:

Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Treatment:

Drug: Vildagliptin (LAF237)

Drug: Metformin

Drug: Insulin

Placebo

Placebo Comparator group

Description:

In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Treatment:

Drug: Placebo

Drug: Metformin

Drug: Insulin