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)

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Dyslipidemia; Type 2 Diabetes

Treatments: Drug: Jinlida granules; Drug: placebo granules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02035644

CCEMD021

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups, including a placebo group

Jinlida granules

Experimental group

Description:

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

Treatment:

Drug: Jinlida granules

placebo granules

Placebo Comparator group

Description:

placebo prepared in indistinguishable granules

Treatment:

Drug: placebo granules