Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorChong Kun Dang Pharmaceutical
About this trial
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SGLT2 inhibitor
DrugSGLT2 inhibitor class of drugs
Thiazolidinedione
DrugThiazolidinedione class of drugs
DPP-4 inhibitor
DrugDPP4 inhibitor class of drugs
Treatment groups
10,000 Participants
are divided into 4 treatment groupsGroup A: Metformin/DPP4i/SGLT2i2 interventions
Group B: Metformin/DPP4i/TZD2 interventions
Group C: Metformin/SGLT2i/DPP4i2 interventions
Group D: Metformin/SGLT2i/TZD2 interventions
Trial outcomes
Primary outcomes
1
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period.
Time frame
Up to 24 monthsSecondary outcomes
1
Changes in HbA1c
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
Time frame
3, 6, (9), 12, 18, and 24 months2
Changes in FPG
Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
Time frame
3, 6, (9), 12, 18, and 24 months3
Percentage of Subjects with HbA1c < 7.0%
Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group
Time frame
3, 6, (9), 12, 18, and 24 months4
Percentage of Subjects with HbA1c < 6.5%
Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group
Time frame
3, 6, (9), 12, 18, and 24 monthsOther outcomes
1
Changes in Weight
Changes in Weight(kg) Compared to Baseline in Each Combination Group
Time frame
3, 6, (9), 12, 18, 24 months2
Changes in waist circumference
Changes in waist circumference(cm) compared to Baseline in Each Combination Group
Time frame
12 and 24 months3
Changes in body composition(protein mass)
Change in total protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.
Time frame
12 and 24 months4
Changes in body composition(protein mass)
Change in protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.
Time frame
12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov