Title
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)
Phase
Phase 4Lead Sponsor
Jiao Tong UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Type 2 Diabetes DyslipidemiaIntervention/Treatment
jinlida ...Study Participants
360The 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.