Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months

• The patient is required to have HbA1c 6.5-11.0%

• BMI in the range of 22-48 kg/m2

Exclusion Criteria:

• Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)

• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months

• Congestive heart failure requiring pharmacologic treatment

• Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention

• Liver disease such as cirrhosis or chronic active hepatitis