Quadruple Oral Combination Therapy for Type 2 Diabetes Mellitus : Glycemic Control by Thiazolidinedione (TZD) or Sodium Glucose Co-transporter 2 (SGLT-2) Inhibitor as an add-on Therapy in Type 2 Diabetes Mellitus After Failure of an Oral Triple Antidiabetic Regimen
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      In the treatment of type 2 diabetes (T2D), the number of patients requiring combination
      therapy of oral antidiabetic agents (OADs) is more than 70%. Especially in Korea, the
      tendency to avoid insulin therapy is relatively higher than other countries, therefore, the
      need for combination therapy of OADs is quite high. However, according to the current
      guidelines, clinicians are recommended to prescribe three or fewer OADs as the combination
      therapy for T2D. Recently, various OADs have been developed, and it is expected that
      quadruple combination therapy of OADs would be quite effective to lower blood glucose levels.
      In the present study, the investigators designed the study to compare the efficacy and safety
      of quadruple combination therapy; thiazolidinedione (TZD) vs. SGLT-2 inhibitor as an add-on
      therapy to triple combination therapy (Metformin, Sulfonylurea, Dipeptidyl peptidase-4(DPP-4)
      inhibitors). Quadruple combination therapy group with the SGLT-2 inhibitor will be considered
      as active control group, because it have shown non-inferior glycemic efficacy to the
      conventional insulin conversion therapy in a previous clinical study. Patients who could not
      achieve the target blood glucose level (7% <HbA1c ≤ 10%) under the triple combination therapy
      (Metformin, Sulfonylurea, DPP-4 inhibitors) for more than 12 weeks will be enrolled in this
      prospective, open-label, randomized, parallel comparison, multicenter clinical trial.
      Subjects in each group (60 patients/group) will be treated with TZD-containing quadruple
      therapy or SGLT-2 inhibitor-containing quadruple therapy for 24 weeks. The investigators will
      evaluate the glycemic efficacy and safety of each group. Primary outcome is the 24
      week-change of HbA1c from baseline levels.
    


Intervention name(s): TZD group; SGLT-2 group
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 15mg (Acpio®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM(type 2 diabetes mellitus) patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of pioglitazone : from 15mg to 30mg; Empagliflozin 10mg (Jardiance®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of empagliflozin : from 10mg to 25mg
Other intervention name(s): Acpio; Jardiance
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, open label, randomized, parallel, multicenter clinical trial
Masking: None (Open Label)
Primary purpose: Treatment