Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)
This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
196
Once a day, Oral administration
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
RECRUITINGVariance in HbA1c from baseline to 24 weeks on study drug
Change in HbA1c
Time frame: 24 weeks
Variance in HbA1c from baseline to 12 weeks on study drug
Change in HbA1c
Time frame: 12 weeks
Variance in FPG from baseline to 12, 24 weeks on study drug
Change in Fasting Plasma Glucose(FPG)
Time frame: 12, 24 weeks
Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug
Change in TC, TG, HDL, LDL
Time frame: 12, 24 weeks
Variance in FLI(Fatty Liver Index), AST, ALT, r-GTP, ALP, HSI(Hepatic steatosis index), Total bilirubin, Albumin, Protein from baseline to 12 and 24 weeks after study drug administration
FLI(Fatty Liver Index)= 1/(1+exp(-x))×100 HSI(Hepatic steatosis index) = 8×ALT/AST+BMI(+2, if type 2 diabetes yes, +2 if female)
Time frame: 12, 24 weeks
Variance in Kidney value from baseline to 12, 24 weeks on study drug
Kidney value: eGFR(CKD-EPI fomulation) ACR(Albumin to Creatine ratio), Creatinine
Time frame: 12, 24 weeks
Variance in body weight from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Percentage of patients achieving HbA1c of 7.0% or 6.5% or less at 12 and 24 weeks post study drug administration compared to baseline
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Percentage of patients achieving HbA1c of 7.0% or 6.5% or less
Time frame: 12, 24 weeks
Variance in Insulin from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Percentage of subjects prescribed an rescue drug during this study
rescue drug
Time frame: during 24weeks(study duration/per subject)
Variance in waist measurement from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Variance in BMI from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Variance in blood pressure from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks
Variance in c-peptide from baseline to 12, 24 weeks on study drug
Time frame: 12, 24 weeks