24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Acarbose
Intervention description: The dose of saxaglitpin will be 5mg oral qd.; Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.
Intervention MeSH terms: Saxagliptin; Acarbose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 689.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Saxagliptin; Acarbose; Type 2 Diabetes; Metformin

Summary:

      SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active
      Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin
      Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes
      Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with type 2 diabetes mellitus

          2. Men and women (non-pregnant and using a medically approved birth-control method) aged
             at least 18 years at screening.

          3. T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to
             screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated
             dose), but not more than the maximum dose specified in the label

          4. HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local
             laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central
             laboratory)

          5. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)

          6. Able and willing to provide written informed consent and to comply with the study
             protocol

        Exclusion Criteria:

          1. Women who are pregnant, intending to become pregnant during the study period,
             lactating females, or women of child-bearing potential not using highly effective,
             medically approved birth control methods.

          2. Diagnosis or history of:

               1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary
                  forms of diabetes, eg, acromegaly or Cushing's syndrome.

               2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma
                  within the past 6 months.

          3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor
             agonists within the past one year.

          4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin
             conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.

          5. Treatment with any anti-diabetic medication for more than 7 consecutive days other
             than metformin in the last 8 weeks prior to screening