A study on the characteristics of Korean type 2 diabetes mellitus patients suitable for the treatment of GLP-1 agonist
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004379
- Lead Sponsor
- Korea University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
Patients are eligible to be included in the study only if they meet all of the following criteria:
1. Have been diagnosed with type 2 diabetes mellitus, and
2. are over 20 years old and under 70 years old, and
3. Have HbA1c>7% despite taking two or more oral hypoglycemic agents including metformin and sulfonylurea, or despite the administration of two or more hypoglycemic agents including basal insulin for at least 3 months
Patients will be excluded from study enrollment if they meet any of the following criteria at screening:
1. Have type 1 diabetes mellitus (T1DM)
2. Have any of the following conditions: acute or chronic hepatitis, liver cirrhosis, or chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2, or congestive heart failure
3. Have a history of psychiatric disorder or untreated malignancy
4. Have evidence of a active autoimmune abnormality (for example, lupus or rheumatoid arthritis) or active infectious disease, or chronic obstructive pulmonary disease.
5. Have received systemic glucocorticoids for 1 week or more within 6 months
6. Have been treated with weight loss drugs within 6 months
7 Have been treated with GLP-1 agonists within 6 months
8. are pregnant or lactating women or those who plan to conceive during the study or within 3 months of the end of the study.
9. Have body mass index < 18.5 kg/m2
10. Have familial or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2
11. Had acute or chronic pancreatitis any time prior to study entry
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the mean changes in HbA1c levels
- Secondary Outcome Measures
Name Time Method the mean changes in ectopic fat (visceral fat, intrahepatic fat, intrapancreatic fat) amounts;the mean changes in body mass index levels;the mean changes in waist circumferences;the mean changes in food craving scores;the mean changes in betatrophin levels