A randomized, double-blind, multi-center, active controlled, Investigator Initiated Trial (IIT) to evaluate the efficacy and safety of adding SGLT-2 inhibitor or switching DPP-4 inhibitor to SGLT-2 inhibitor and Lobeglitazone as triple oral combination therapy to patients with Type 2 diabetes mellitus inadequately controlled by DPP-4 inhibitor and Metformi
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005497
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 260
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c
- Secondary Outcome Measures
Name Time Method 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]