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

• Mean change in fasting plasma glucose (FPG) from Baseline to Month 12 [ Time Frame: Baseline, Month 12 (week 52) ] [ Designated as safety issue: No ]
  To examine the change in FPG from baseline to Month 12
• Percentage of patients with HbA1c <7.0% [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  Determine percentage of patients achieving HbA1c <7.0% at month 12 between the treatment arms
• Percentage of overall drug compliance in 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  Determine percentage of overall drug compliance in 12 months between treatment arms
• Percentage patients with adverse events, serious adverse events and death as an assessment of overall safety and tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  This analysis will report percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death will be reported.

• Mean change in FPG from Baseline to Month 12 [ Time Frame: Baseline, Month 12 (week 52) ] [ Designated as safety issue: No ]
  To examine the change in FBG from baseline to Month 12
• Percentage of patients with HbA1c <7.0% [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  Determine percentage of patients achieving HbA1c <7.0% at month 12 between the treatment arms
• Percentage of overall drug compliance in 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  Determine percentage of overall drug compliance in 12 months between treatment arms
• Percentage patients with adverse events, serious adverse events and death as an assessment of overall safety and tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  This analysis will report percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death will be reported.

The purpose of this study is to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study is 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.

• Drug: Vildagliptin
  Vildagliptin 50mg capsule
  Other Names:

  • Galvus
  • LAF237
• Drug: Metformin
  Metformin maximum tolerance dose

• Active Comparator: Vildagliptin 50mg once daily (QD)
  Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
  Interventions:

  • Drug: Vildagliptin
  • Drug: Metformin
• Active Comparator: Vildagliptin 50mg twice daily (BID)
  Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
  Interventions:

  • Drug: Vildagliptin
  • Drug: Metformin

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

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

Other protocol defined inclusion/exclusion criteria may apply