Type 2 Diabetes
Conditions
Keywords
triple combination therapy, sitagliptin, dapagliflozin, lobeglitazone
Brief summary
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.
Detailed description
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.
Interventions
DRUGSitagliptin
100mg qd per oral during 24months compared with other treatment groups
DRUGDapagliflozin
10mg qd per oral during 24months compared with other treatment groups
DRUGLobeglitazone
0.5mg qd per oral during 24months compared with other treatment groups
DRUGGlimepirde
DRUGMetformin
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 20 ≤ Age \< 80 years * HbA1c ≥ 7 % * combination therapy with glimepiride and metformin over 2 months. * dosage of glimepiride : 1-8mg/day * dosage of metformin : 500-2550mg/day
Exclusion criteria
* Type 1 diabetes, gestational diabetes, or secondary forms of diabetes * Contraindication to sitagliptin or dapagliflozin or lobeglitazone * Pregnant or breast feeding women * Medication which affect glycemic control (ex. steroid) * Disease which affect efficacy and safety of drugs * Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc) * Not appropriate for oral antidiabetic agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic target goal achievement rate | 24 months | HbA1c\< 7.0% without hypoglycemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beta-cell function | 6 and 24 months | Beta-cell function |
| insulin resistance | 6 and 24 months | insulin resistance |
| Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) | 3,6,9,12,16,20 and 24months | Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) |
| Lipid profile | 3,6,9,12,16,20 and 24months | Lipid profile |
| Change of HbA1c | 3,6,9,12,16,20 and 24months | Change of HbA1c |
| Glycemic target goal achievement rate | 12 months | HbA1c\< 7.0% without hypoglycemia |
| Body fat | 6,12 and 24 months | Body fat |
| urine microalbumin to creatinine ratio | 6,12 and 24 months | urine microalbumin to creatinine ratio |
Other
| Measure | Time frame | Description |
|---|---|---|
| hypoglycemia | 3,6,9,12,16,20 and 24months | hypoglycemia |
| body weight change | 6 and 24 months | body weight change |
Countries
South Korea
Outcome results
None listed