Overview

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)

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborators:
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Shijiazhuang Yiling Pharmaceutical company, LTD
Criteria
Inclusion Criteria:

1. age of 20-70 years;

2. diagnosed with type 2 diabetes inadequately controlled under life style intervention
with 3 months before screening;

3. HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline;

4. 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)

5. body mass index (BMI): 20
Exclusion Criteria:

1. moderate or severe liver dysfunction, abnormal renal function;

2. severe dysfunction of the heart;

3. histories of acute diabetic complications including diabetic ketoacidosis or
hyperosmolar hyperglycemic non-ketotic coma within 3 months;

4. psychiatric disease or severe infection;

5. pregnancy or planned pregnancy;

6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3
months;

7. use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive
growth hormone therapy within 6 months;

8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of
diabetes;

9. history of malignant tumor within 5 years.