To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome proliferator-activated receptors (PPARs) agonists. But, there have been few studies about the glucose lowering effect of these drugs in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin. Hence, the researchers plan to investigate the efficacy and safety of these drugs in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
100mg qd per oral during 24months compared with other treatment groups
10mg qd per oral during 24months compared with other treatment groups
0.5mg qd per oral during 24months compared with other treatment groups
Soo Lim
Seongnam-si, Gyeonggi-do, South Korea
Glycemic target goal achievement rate
HbA1c\< 7.0% without hypoglycemia
Time frame: 24 months
Beta-cell function
Beta-cell function
Time frame: 6 and 24 months
insulin resistance
insulin resistance
Time frame: 6 and 24 months
Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
Time frame: 3,6,9,12,16,20 and 24months
Lipid profile
Lipid profile
Time frame: 3,6,9,12,16,20 and 24months
Body fat
Body fat
Time frame: 6,12 and 24 months
urine microalbumin to creatinine ratio
urine microalbumin to creatinine ratio
Time frame: 6,12 and 24 months
Change of HbA1c
Change of HbA1c
Time frame: 3,6,9,12,16,20 and 24months
Glycemic target goal achievement rate
HbA1c\< 7.0% without hypoglycemia
Time frame: 12 months
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