Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582230

CLAF237A23155

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Enrollment: 293 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
• C-peptide >0.6 ng/ml (>0.20 nmol/L).
• HbA1c ≥7.5 to ≤11% at Visit 1
• Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
• Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
• Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion criteria

Patients fulfilling any of the following criteria are not eligible for participation in the study

• Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
• Pregnant or lactating women
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Current diagnosis of congestive heart failure (NYHA III or IV).
• Myocardial infarction (MI) within the past 6 months
• Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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293 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Description:

Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Treatment:

Drug: Vildagliptin

Placebo

Placebo Comparator group

Description:

Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Treatment:

Drug: Placebo