None listed
Conditions
Interventions
Drug : 1. Single additional therapy group
1) Single additional therapy group 1
Pre-dining basal insulin (single administration or merged with metformin)
+ Zemiglo(gemigliptin 50mg) qd(one a day)
2) Si
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosed with type 2 diabetes (according to the American diabetes association standard) by a blood test (2) Patients using basal insulin and metformin at least 1,000 mg / day with stable volume for at least 8 weeks before Visit 1 (Screening) (3) Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 12% (4) 18 Years to 74 Years (Adult) (5) Body mass index of 20 through 35 kilogram per meter square (kg/m^2) (6) Estimated glomerular filtration rate (eGFR) of at least 45 milliliter/minute (mL/min)/1.73 meter square (m^2) (7) Basal C-peptide level or more 1.0ng/ml
Exclusion criteria
Exclusion criteria: (1) Patient with hypersensitivity reaction to the drug in this study or a drug containing a homologous system (eg, a history of hypersensitivity to SGLT2i or DPP4i) (2) Have the following medical history or history of surgery / treatment -Type 1 diabetes -Diabetic ketone acidosis at screening -Diabetic coma or pre-coma at screening -Experience cardiovascular events (acute coronary artery disease, cerebral infarction, transient ischemic attack) within 3 months of screening criteria -Patients diagnosed with solid or blood cancers and are or are planning to be treated -Past history of acute pancreatitis -Urinary tract or genital infections within the last year -Suspected alcohol abuse - (3) have the following diseases or signs -Patient determined to require continuous systemic steroid treatment at screening -Severe Infectious Disease, Before and After Surgery, Severe Trauma -Symptoms of urination disorder, urination, hematuria, urinary tract that are not controlled by drugs due to tension incontinence, neurogenic bladder, and enlarged prostate. -Pregnant and lactating women (for women of childbearing age, urine ß-hCG test at the time of registration)-Persons suspected of alcohol abuse Unstable mental illness with no controlled symptoms. Uncontrolled hyperglycemia> 270 mg / dl (after 8 hours fasting) -Those who complain of weight loss of 10% within 3 months with polyphagia,polyuria, polydipsia at screening -Severe liver dysfunction (over 3 times normal range of liver function test AST, ALT, ALP) -Severe heart failure (New York Heart Association Class II or higher)- Severe Inflammatory disease, Severe trauma after surgery (4) Genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption) (5) Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at Screening(However, if no medication has been taken due to observational research, participation in this clinical trial is possible.) (6) For other reasons Determines that the investigtor is not suitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with glycated hemoglobin decreased by more than 0.5% without medication due to hypoglycemia, weight gain * and side effects at 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbA1c from 24th week(Visit 5) of treatment starting point;Changes in fasting plasma blood sugar from 24th week(Visit 5) of treatment starting point;On the 24th week of treatment, Percentage of patients reaching 7.0% and 6.5% or less HbA1c due to hypoglycemia, weight gain, and without interruption of drugs due to side effects;Changes in Mean Amplitude of Glycemic Excursio(MAGE) measured by continuous glucose monitoring system(CGMS) from 24th week(Visit 5) (15 persons per army, 45 persons in total);Changes in weight from 24th week(Visit 5) of treatment starting point;Changes in systolic blood pressure from 24th week(Visit 5) of treatment starting point;Changes in Urine Albumin-to-Creatinine Ratio(UACR) from 24th week(Visit 5) of treatment starting point;Adverse event/Serious Adverse event (Major Adverse event : Hypoglycemia, gastro-intestinal tract adverse event, Urinary tract infection, Genital infection, Body fluid loss, Pancreatitis, Severe skin reaction, Hypersensitive response);Vital sign;Biochemical examination / Hematological examination abnormal;Hypoglycemia : Plasma glucose = 70mg/dL or Hypoglycemia that needs help from others | — |
Countries
Korea, Republic of
Contacts
Public ContactSingon Kim
Korea University Anam Hospital
Outcome results
None listed