Koreanische Studie zur Sicherheit und Wirksamkeit der OAD -Dreifachtherapie bei Typ -2 -Diabetes (TRIO)
Eine multizentrische, prospektive, nicht interventionelle Beobachtungsstudie zur Bewertung der Sicherheit und Wirksamkeit der OAD-Dreifachtherapie bei koreanischen Diabetikern mellituspatienten
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Soo Lim, M.D, Ph.D.
- Telefonnummer: 82-2-6373-0773
- E-Mail: limsoo@snu.ac.kr
Studienorte
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Südkorea
- Rekrutierung
- Seoul National University Bundang Hospital
-
Kontakt:
- Soo Lim, M.D, Ph.D.
- Telefonnummer: 1588-3369
- E-Mail: limsoo@snu.ac.kr
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
Beschreibung
Inclusion Criteria:
- Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
- Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
Exclusion Criteria:
- Patients with type 1 diabetes and secondary diabetes.
- Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
- Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
- End-stage renal disease and hemodialysis patients.
- diabetic ketoacidosis Patients.
- Pregnant and lactating women.
- 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.
- Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
- Anyone else deemed by the investigator to be unsuitable for participation in the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs. |
SGLT2 inhibitor class of drugs DPP4 inhibitor class of drugs |
|
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs. |
DPP4 inhibitor class of drugs Thiazolidinedione class of drugs |
|
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs. |
SGLT2 inhibitor class of drugs DPP4 inhibitor class of drugs |
|
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs. |
SGLT2 inhibitor class of drugs Thiazolidinedione class of drugs |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Zeitfenster: Up to 24 months
|
Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period. |
Up to 24 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in HbA1c
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group |
3, 6, (9), 12, 18, and 24 months
|
|
Changes in FPG
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group |
3, 6, (9), 12, 18, and 24 months
|
|
Percentage of Subjects with HbA1c < 7.0%
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
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%
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
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 time point in each combination group.
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
demographics, previous hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc. |
3, 6, (9), 12, 18, and 24 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in Weight
Zeitfenster: 3, 6, (9), 12, 18, 24 months
|
Changes in Weight(kg) Compared to Baseline in Each Combination Group |
3, 6, (9), 12, 18, 24 months
|
|
Changes in waist circumference
Zeitfenster: 12 and 24 months
|
Changes in waist circumference(cm) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in body composition(protein mass)
Zeitfenster: 12 and 24 months
|
Change in total protein mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(protein mass)
Zeitfenster: 12 and 24 months
|
Change in protein mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(body fat)
Zeitfenster: 12 and 24 months
|
Change in body fat mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(mineral mass)
Zeitfenster: 12 and 24 months
|
Change in mineral mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in Fatty Liver Index
Zeitfenster: 6, 12, 18, and 24 months
|
Changes in Fatty Liver Index compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in AST
Zeitfenster: 6, 12, 18, and 24 months
|
Changes in AST(IU/L) Compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in ALT
Zeitfenster: 6, 12, 18, and 24 months
|
Changes in ALT(IU/L) Compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes Platelet Levels
Zeitfenster: 6, 12, 18, and 24 months
|
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)
Zeitfenster: 6, 12, 18, and 24 months
|
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)
Zeitfenster: 12 and 24 months
|
Changes in HOMA-IR compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in Insulin-Related Test Levels(HOMA-β)
Zeitfenster: 12 and 24 months
|
Changes in HOMA-β(%) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in eGFR
Zeitfenster: 6, 12, 18, and 24 months
|
Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in UACR
Zeitfenster: 6, 12, 18, and 24 months
|
Changes in UACR(mg/g) compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Change in hsCRP
Zeitfenster: 12 and 24 months
|
Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Change in ProBNP(or NT-ProBNP)
Zeitfenster: 12 and 24 months
|
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
Zeitfenster: 3, 6, (9), 12, 18, and 24 months
|
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)
Zeitfenster: 24 month
|
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
Zeitfenster: 24 month
|
Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group |
24 month
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des endokrinen Systems
- Stoffwechselerkrankungen
- Störungen des Glukosestoffwechsels
- Diabetes Mellitus
- Ernährungs- und Stoffwechselerkrankungen
- Diabetes mellitus, Typ 2
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Hypoglykämische Mittel
- Proteaseinhibitoren
- Enzyminhibitoren
- Pharmakologische Maßnahmen
- Chemische Handlungen und Verwendung
- Natrium-Glucose-Transporter 2-Inhibitoren
- 2,4-Thiazolidindion
- Dipeptidyl-Peptidase-IV-Inhibitoren
Andere Studien-ID-Nummern
- D141_01DM2303
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