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A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.
Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin/DPP4i/SGLT2i | Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs. |
| |
| Metformin/DPP4i/TZD | Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs. |
| |
| Metformin/SGLT2i/DPP4i | Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs. |
| |
| Metformin/SGLT2i/TZD | Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | SGLT2 inhibitor class of drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs. | Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration). | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c | Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group | 3, 6, (9), 12, 18, and 24 months |
| Changes in FPG | Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Weight | Changes in Weight(kg) Compared to Baseline in Each Combination Group | 3, 6, (9), 12, 18, 24 months |
| Changes in waist circumference | Changes in waist circumference(cm) compared to Baseline in Each Combination Group (body composition in body water(L), protein(kg), minerals(kg), and body fat(kg)) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim, M.D, Ph.D. | Contact | 82-2-6373-0773 | limsoo@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| C089946 | 2,4-thiazolidinedione |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| Thiazolidinedione | Drug | Thiazolidinedione class of drugs |
|
| DPP-4 inhibitor | Drug | DPP4 inhibitor class of drugs |
|
| 3, 6, (9), 12, 18, and 24 months |
| Percentage of Subjects with HbA1c < 7.0% | Percentage of Subjects with HbA1c < 7.0% in Each Combination Group | 3, 6, (9), 12, 18, and 24 months |
| Percentage of Subjects with HbA1c < 6.5% | Percentage of Subjects with HbA1c < 6.5% in Each Combination Group | 3, 6, (9), 12, 18, and 24 months |
| Factors influencing HbA1c change at each endpoint for each combination group. | demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc. | 24 month |
| 12 and 24 months |
| Changes in Fatty Liver Index | Changes in Fatty Liver Index compared to Baseline in Each Combination Group | 6, 12, 18, and 24 months |
| Changes in AST | Changes in AST(IU/L) Compared to Baseline in Each Combination Group | 6, 12, 18, and 24 months |
| Changes in ALT | Changes in ALT(IU/L) Compared to Baseline in Each Combination Group | 6, 12, 18, and 24 months |
| Changes Platelet Levels | Changes in Platelet(10^3/uL) Levels Compared to Baseline in Each Combination Group | 6, 12, 18, and 24 months |
| Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG) | Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group | 6, 12, 18, and 24 months |
| Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β) | Changes in HOMA-IR(%), HOMA-(%) compared to Baseline in Each Combination Group | 12 and 24 months |
| Changes in eGFR | Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group | 12 and 24 months |
| Changes in UACR | Changes in UACR(mg/g) compared to Baseline in Each Combination Group | 12 and 24 months |
| Change in hsCRP | Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group | 12 and 24 months |
| Change in ProBNP(or NT-ProBNP) | Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group | 12 and 24 months |
| Change in PP2 Compared to Baseline in Each Combination Group | Change in PP2(mg/dL) compared to Baseline in Each Combination Group. | 3, 6, (9), 12, 18, and 24 months |
| Incidence Rate of Major Adverse Cardiovascular Events(MACE) | Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group | 24 month |
| Incidence Rate of Diabetic Microvascular Events | Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group | 24 month |
| D004700 | Endocrine System Diseases |
| D045505 | Physiological Effects of Drugs |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |