Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, Korean patients, Observational study, OAD triple therapy
Brief summary
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Detailed description
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.
Interventions
DRUGSGLT2 inhibitor
SGLT2 inhibitor class of drugs
Thiazolidinedione class of drugs
DRUGDPP-4 inhibitor
DPP4 inhibitor class of drugs
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment. 2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment. 3. 7.0% ≤ HbA1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment. 4. Voluntarily give written informed consent after being told about the study.
Exclusion criteria
1. Patients with type 1 diabetes and secondary diabetes. 2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment. 3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study. 4. End-stage renal disease and hemodialysis patients. 5. diabetic ketoacidosis Patients. 6. Pregnant and lactating women. 7. Patients who are contraindicated by any of the Precautions for Use in the license for the drug being administered during the study, given the observational nature of the study under routine practice. 8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients. 9. Anyone else deemed by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs. | 24 month | Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c | 3, 6, (9), 12, 18, and 24 months | Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group |
| Changes in FPG | 3, 6, (9), 12, 18, and 24 months | Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group |
| Percentage of Subjects with HbA1c < 7.0% | 3, 6, (9), 12, 18, and 24 months | Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group |
| Percentage of Subjects with HbA1c < 6.5% | 3, 6, (9), 12, 18, and 24 months | Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group |
| Factors influencing HbA1c change at each endpoint for each combination group. | 24 month | demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG) | 6, 12, 18, and 24 months | Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group |
| Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β) | 12 and 24 months | Changes in HOMA-IR(%), HOMA-(%) compared to Baseline in Each Combination Group |
| Changes in eGFR | 12 and 24 months | Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group |
| Changes in UACR | 12 and 24 months | Changes in UACR(mg/g) compared to Baseline in Each Combination Group |
| Changes in Weight | 3, 6, (9), 12, 18, 24 months | Changes in Weight(kg) Compared to Baseline in Each Combination Group |
| Change in ProBNP(or NT-ProBNP) | 12 and 24 months | Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group |
| Change in PP2 Compared to Baseline in Each Combination Group | 3, 6, (9), 12, 18, and 24 months | Change in PP2(mg/dL) compared to Baseline in Each Combination Group. |
| Incidence Rate of Major Adverse Cardiovascular Events(MACE) | 24 month | Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group |
| Incidence Rate of Diabetic Microvascular Events | 24 month | Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group |
| Change in hsCRP | 12 and 24 months | Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group |
| Changes in waist circumference | 12 and 24 months | 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)) |
| Changes in Fatty Liver Index | 6, 12, 18, and 24 months | Changes in Fatty Liver Index compared to Baseline in Each Combination Group |
| Changes in AST | 6, 12, 18, and 24 months | Changes in AST(IU/L) Compared to Baseline in Each Combination Group |
| Changes in ALT | 6, 12, 18, and 24 months | Changes in ALT(IU/L) Compared to Baseline in Each Combination Group |
| Changes Platelet Levels | 6, 12, 18, and 24 months | Changes in Platelet(10\^3/uL) Levels Compared to Baseline in Each Combination Group |
Countries
South Korea
Contacts
Primary ContactSoo Lim, M.D, Ph.D.
Outcome results
None listed