Study on the Efficacy aNd Safety of Jinlida Granules in Patients With Inadequately cOntrolled tYpe-2 Diabetes and dysLIpidemia Under liFe Style Intervention (ENJOY LIFE Study)
The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention.
Jinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes
placebo prepared in indistinguishable granules
Inclusion Criteria: age of 20-70 years; diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening; HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline; diagnosed with dislipidemia with triglycerides>150mg/dL (1.70mmol/L), and/or total cholesterol >200mg/dL (5.16mmol/L), and/or LDL-c>100mg/dL (2.58mmol/L) body mass index (BMI): 20<BMI<40 kg/m2; Exclusion Criteria: moderate or severe liver dysfunction, abnormal renal function; severe dysfunction of the heart; histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months; psychiatric disease or severe infection; pregnancy or planned pregnancy; use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months; use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months; diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes; history of malignant tumor within 5 years.