Type2diabetes
Conditions
Keywords
Dapagliflozin, Pioglitazone, DPP-4 inhibitor
Brief summary
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)
Detailed description
This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial
Interventions
DRUGDW6012(Dasidiem tab. 10/100mg)
Once a day, Oral administration
Sponsors
Dong Wha Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes who are 19 years of age or older at the date of written consent * Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening * HbA1c ≤ 7.0% ≤ HbA1c \< 10% at time of screening * BMI ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening * Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent
Exclusion criteria
* Patients with type 1 diabetes * Have a BMI \> 40 kg/m2 * Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) \< 45 mL/min/1.73 m2 * Patients with end stage renal disease or patients on dialysis * Patients with uncontrolled heart failure (NYHA class III - IV) * Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit * Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis * Patients with diabetic coma or precoma * Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors. * Patients with hematuria * Patients who receiving treatment for thyroid dysfunction at the time of screening * Malnourished, starving, or debilitated subjects * Patients with pituitary insufficiency or adrenal insufficiency * Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal * Patients with severe infectious diseases, perioperative, or clinically significant trauma * Have a history of substance abuse * Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit * Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids * Patients with a history of malignancy within the last 5 years * Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied * Pregnant and breastfeeding women * Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients * Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption. * Any other person deemed by the investigator to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variance in HbA1c from baseline to 24 weeks on study drug | 24 weeks | Change in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variance in FPG from baseline to 12, 24 weeks on study drug | 12, 24 weeks | Change in Fasting Plasma Glucose(FPG) |
| Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug | 12, 24 weeks | Change in TC, TG, HDL, LDL |
| 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 | 12, 24 weeks | 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) |
| Variance in Kidney value from baseline to 12, 24 weeks on study drug | 12, 24 weeks | Kidney value: eGFR(CKD-EPI fomulation) ACR(Albumin to Creatine ratio), Creatinine |
| Variance in body weight from baseline to 12, 24 weeks on study drug | 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 | 12, 24 weeks | Percentage of patients achieving HbA1c of 7.0% or 6.5% or less |
| Variance in HbA1c from baseline to 12 weeks on study drug | 12 weeks | Change in HbA1c |
| Percentage of subjects prescribed an rescue drug during this study | during 24weeks(study duration/per subject) | rescue drug |
| Variance in waist measurement from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
| Variance in BMI from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
| Variance in blood pressure from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
| Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
| Variance in c-peptide from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
| Variance in Insulin from baseline to 12, 24 weeks on study drug | 12, 24 weeks | — |
Countries
South Korea
Outcome results
None listed