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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02035644

Enrollment

360

Registered

2014-01-14

Start date

2014-02-28

Completion date

Unknown

Last updated

2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Type 2 Diabetes

Brief 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.

Interventions

DRUGJinlida granules

DRUGplacebo granules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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\<BMI\<40 kg/m2;

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.

Design outcomes

Primary

Measure	Time frame
change in HbA1c levels	16 weeks

Secondary

Measure	Time frame
fasting, postload 30-min and 2-h serum insulin	16 weeks
serum lipids	16 weeks
glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp	16 weeks
fasting, postload 30-min and 2-h plasma glucose	16 weeks
metabolomic parameters	16 weeks
BMI	16 weeks
blood pressures	16 weeks
incretins	16 weeks

Countries

China

Contacts

Primary ContactGuang Ning, MD, PHD

8621-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026