A Multicenter, Prospective, Randomized, Open-label, Parallel-group, Phase 4 Study to Compare the Efficacy and Safety of Triple Combination Therapy in Korean Patients with Type 2 diabetes Who Had Inadequate Glycemic Control with Metformin and DPP-4 inhibitor Combination Therapy
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0006731
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 186
1) Patients with type 2 diabetes between 20 to 75 years of age
2) 20= BMI =40 at the Screening Visit
3) Those who have been taking Metformin 1000 mg/day (immediate-release and hyper-release) + DPP-4 inhibitor* (metformin 1,000 mg/day + DPP4 inhibitor) at the same dose for at least 12 weeks prior to the Screening Visit.
* The types and doses of DPP-4 inhibitors allowed for combination therapy in this study are as follows.
Sitagliptin 100 mg/day
Vildagliptin 100mg/day
Saxagliptin 5 mg/day
Linagliptin 5 mg/day
Gemigliptin 50 mg/day
Teneligliptin 20 mg/day
Alogliptin 25 mg/day
Evogliptin 5 mg/day
Anagliptin 200 mg/day
4) 7%= HbA1c =10% at the Screening Visit
5) Those who spontaneously decides to participate in a Clinical Trial after hearing, fully understanding the detailed explanation of the Clinical Trial and consents in Writing
1) Patients with type 1 diabetes, gestational diabetes, or secondary diabetes
2) Patients who have used SU, TZD, SGLT2i, insulin, and GLP-1 acceptor agonists within 8 weeks of screening visit
3) Patients with a history of hypersensitivity reactions to metformin, glimepiride, TZD, SGLT2i, DPP-4inhibitors, which are Investigational Products.
4) Patients with moderate or severe renal impairment (eGFR <60), end stage renal disease, or under dialysis
5) In case of ALT or AST at screening visit exceeds 2.5 times the normal upper limit
6) Patients with acute or chronic metabolic acidity including diabetic ketoacidosis and patients with a history of ketoacidosis
7) Patients with heart failure above NYHA class III
8) Patients with arrhythmia who have a history of myocardial infarction, unstable angina, and coronary artery bypass within 24 weeks of screening visit or need treatment
9) Patients with a history of severe hypoglycemia
10) Patients who have been tested to administer radiiodic contrast substances into blood vessels within 48 hours or scheduled during clinical trials based on the time of the screening visit
11) Patients with a history of malignant tumors within 5 years prior to the screening visit (except those diagnosed with underlying cell cancer, squamous cell cancer, or intraepithelial cancer in the cervix, or those who have never been treated or have no possibility of recurrence for at least 5 years prior to visit 1)
12) Patients who are receiving treatment for thyroid dysfunction at the Screening Visit (However, among patients undergoing thyroid hormone replacement therapy, those who have maintained a stable dose for more than 6 weeks before the screening visit can participate)
13) Patients who have chronically administered systemic corticosteroid within 8 weeks (over 14 days) as of the time of the screening visit.
14) Pregnant or lactating women
15) Patients who are judged to be inappropriate to participate in a clinical trial based on the Investigator judgement
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c response rate
- Secondary Outcome Measures
Name Time Method FPG, HbA1c response rate, Weight increase/loss and/or Rate of reaching target HbA1c without hypoglycemia, HOMA-beta, HOMA-IR, Lipid parameter (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride), AST, ALT, r-GT, serum Cr, eGFR, urine albumin/creatinine ratio, Rescue therapy rate, Weight, Blood pressure