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 4
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    jinlida ...
  • Study Participants

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.
Study Started
Feb 28
Primary Completion
Feb 28
Last Update
Jan 14

Drug Jinlida granules

Drug placebo granules

Jinlida granules Experimental

Jinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes

placebo granules Placebo Comparator

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.
No Results Posted