Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glimepiride; Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human; Vildagliptin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of type 2 diabetes mellitus.

• Contraindicated or intolerant to take metformin.

• HbA1c of ≥ 7.0% and ≤ 8.5%

• Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.

• Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month

• Patients taking sulfonylurea for longer than 5 years

• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures

• pregnancy

• Other protocol-defined inclusion/exclusion criteria may apply