Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

• Status: Completed
• Trial end date: 2015-10-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Metformin; Vildagliptin

Criteria

Inclusion Criteria:

1. Male or Female in age ≥18 at Visit 1

2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months

3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%

4. With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin

Key Exclusion Criteria:

1. Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1

2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment

3. Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption

4. Pregnant women or breastfeeding women at the time of enrolment

5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment