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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: vildagliptin/metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196546

CLMF237ATH01

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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161 participants in 1 patient group

Vildagliptin/metformin

Experimental group

Treatment:

Drug: vildagliptin/metformin