VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether the initiation of a vildagliptin plus
      metformin combination regimen would result in more durable glycemic control than metformin
      monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
    

Detailed description: 
      This was a multi-center, double-blind, placebo-controlled, 2-arm, parallel group study with a
      run-in period and up to 5 years treatment period. Following a screening visit (Visit 1) and a
      screening period of up to 2 weeks, treatment-naïve patients, meeting all eligibility criteria
      entered the run-in period at Visit 2.

        -  Run-in period: At Visit 2, in all eligible patients, metformin treatment was initiated
           and/or up-titrated. At the end of the 3-week run-in period, patients who were able to
           tolerate a total dose of at least 1000 mg and up to 2000 mg daily proceeded to
           randomization and started in Period 1.

        -  Period 1 (vildagliptin/metformin combination versus metformin): At Visit 3, patients
           were randomized 1:1 to one of the following study regimens:

             -  Metformin up to 1000 mg bid plus vildagliptin 50mg bid or

             -  Metformin up to 1000 mg bid plus matching placebo bid

      The duration of Period 1 could differ between patients depending on the time when the second
      of two HbA1c measurements taken at two consecutive visits after randomisation confirmed HbA1c
      ≥ 7.0%.

      • Period 2 (vildagliptin/metformin combination versus vildagliptin add-on to metformin): In
      the case of two consecutive HbA1c measurements ≥7.0% from two consecutive study visits during
      Period 1, patients who were randomised to the placebo arm in Period 1 received vildagliptin
      50 mg bid. Patients who were randomised to the active vildagliptin 50 mg bid arm in Period 1
      continued to receive vildagliptin 50 mg bid. All patients continued to take their metformin
      dose unchanged. Period 2 remained masked to the patient and both patients and investigators
      remained masked to the treatment allocation in Period 1.

      If, during Period 2, therapy intensification was required in accordance with the local
      guidelines, the patient entered Period 3. The duration of Period 2 could differ between
      patients. End of Period 2 was considered when insulin treatment was initiated, or
      alternatively when the patient was discontinued because insulin treatment was not initiated
      in Period 3.

      • Period 3 (insulin initiation): In Period 3, patients were to be initiated on open-label
      insulin. The study drug regimen continued unchanged and remained masked to the patient in
      Period 3 and both patients and investigators remained masked to the treatment allocation in
      Period 1.
    

Intervention name(s): Placebo of vildagliptin; vildagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.; Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Other intervention name(s): Placebo; LAF237
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Vildagliptin; Elderly Patients