Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glimepirde, Metformin, Sitagliptin | Active Comparator | Dipeptidyl peptidase-4 (DPP4) inhibitor Sitagliptin |
|
| Glimepirde, Metformin, Dapagliflozin | Active Comparator | Sodium-glucose cotransporter 2 (SGLT2) inhibitors Dapagliflozin |
|
| Glimepirde, Metformin, Lobeglitazone | Active Comparator | Peroxisome proliferator-activated receptor gamma agonist Lobeglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 100mg qd per oral during 24months compared with other treatment groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic target goal achievement rate | HbA1c< 7.0% without hypoglycemia | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell function | Beta-cell function | 6 and 24 months |
| insulin resistance | insulin resistance | 6 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| hypoglycemia | hypoglycemia | 3,6,9,12,16,20 and 24months |
| body weight change | body weight change | 6 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, MD, PHD | SNUBH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soo Lim | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Dapagliflozin | Drug | 10mg qd per oral during 24months compared with other treatment groups |
|
|
| Lobeglitazone | Drug | 0.5mg qd per oral during 24months compared with other treatment groups |
|
|
| Glimepirde | Drug |
|
|
| Metformin | Drug |
|
| Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) | Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) | 3,6,9,12,16,20 and 24months |
| Lipid profile | Lipid profile | 3,6,9,12,16,20 and 24months |
| Body fat | Body fat | 6,12 and 24 months |
| urine microalbumin to creatinine ratio | urine microalbumin to creatinine ratio | 6,12 and 24 months |
| Change of HbA1c | Change of HbA1c | 3,6,9,12,16,20 and 24months |
| Glycemic target goal achievement rate | HbA1c< 7.0% without hypoglycemia | 12 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C529054 | dapagliflozin |
| C546215 | lobeglitazone |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided