None listed
Conditions
Interventions
Drug : This clinical trial was designed as a randomized, double-blind, active-controlled, 52-week and investigator-initiated trial(IIT).
During the screening period of up to 4 weeks, Linagliptin 5.0mg
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects aged over 18 years and under 75 years 2.Subjects diagnosed with type 2 diabetes 3.Among subjects who used the tolerated dose of metformin and the maximum dose of DPP-4 inhibitors for 12 weeks before screening, subjects whose blood glucose is not sufficiently controlled with 7% = HbA1c = 10% at screening 4.Subjects with 20.0 kg/m2 = BMI = 40.0 kg/m2 at screening 5.Subjects with FPG < 270 mg/dL at screening 6.Subjects judged to be able to participate in the trial until the end date after they understand the contents of clinical trial and voluntarily give written consent and then
Exclusion criteria
Exclusion criteria: 1.Subjects with the history of type 1 diabetes, gestational diabetes or secondary diabetes 2.Subjects who have acute metabolic complications within 24 weeks before screening as follows: •Hyperglycemic coma •Ketoacidosis •Hypoglycemia 3.Subjects who have chronic complications within 24 weeks before screening as follows: •Heart failure(NYHA class III & IV) •Cardiovascular and cerebrovascular diseases •Hypertension(Blood pressure is not controlled to less 160/100 mmHg in spite of drug therapy) •Laser therapy performed for proliferative retinopathy 4.Subjects with the history of acute and chronic pancreatitis 5.Subjects with gastrointestinal disorders such as diarrhea, vomiting and dyspepsia 6.Subjects who are in condition before and after all the surgeries except minor surgery with no restrictions on the intake of food and fluid, or have severe infections 7.Subjects who use weight control agents or hypoglycemic drugs except metformin and DPP-4 inhibitors within 12 weeks before screening * However, subjects who temporarily use insulin in an emergency room can be enrolled. 8.Subjects who use systemic steroids within 24 weeks before screening 9.Subjects diagnosed with malignant tumors within 2 years before screening 10.Subjects with allergy or hypersensitivity reaction to the investigational drugs or their ingredients* * Since they contain lactose, subjects have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 11.Subjects who meet any of the following laboratory test items •Less than hemoglobin normal reference value •eGFR < 60 mL/min/1.73 m2 •ALT = 3 X ULN •AST = 3 X ULN 12.Subjects with malnutrition or excessive drinking* * For men, more than 21 standard drinks a week, and for women, more than 14 standard drinks. 1 standard drink is equivalent to 1 and a half glasses of soju(90 mL), 1 can of beer(355 mL), 1 glass of wine(120 mL) and 1 glass of hard liquor(40 mL) 13.Subjects who were prescribed investigational drugs while participating in other clinical trials within 12 weeks before screening, or are currently participating in other clinical trials 14.Pregnant or breast-feeding women 15.Subjects who do not agree with contraception* by medically acceptable method for clinical trial period and for up to 4 weeks after the end of clinical trial *Medically acceptable contraceptive methods: Copper intrauterine device(copper loop), condom, vasectomy, tubal ligation, use of spermicide, vaginal contraceptive pill, subcutaneous implant contraceptive, injectable contraceptives, female condom and oral contraceptive pill lasting at least 12 weeks or more 16.Other than above, subjects who are unable to participate in this clinical trial by the judgment of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in HbA1c at 52 weeks 2)At 26 and 52 weeks - Changes in [Lipid levels(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol) / Glucose metabolism level(fasting glucose, fasting insulin, fasting C-peptide) /insulin resistance(HOMA-IR) and insulin secretion(HOMA-ß) / Adiponectin] - Percentage of subjects who reach blood glucose response defined as HbA1c < 7.0% and HbA1c < 6.5% - Change rate of [Intrahepatic fat content, NFS, FIB-4 Score, Hyaluronic acid, a2-macroglobulin, 1.5-AG] | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Kim
Kangbuk Samsung Medical Center
Outcome results
None listed