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 4

• Conditions: Type 2 Diabetes; Dyslipidemia
• Interventions: Drug: Jinlida granules; Drug: placebo granules

• Registration Number: NCT02035644
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-12
• Study First Submitted QC: 2014-01-12
• Last Update Submitted: 2014-01-12
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14
• Study Start: 2014-02
• Primary Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jinlida granules	Jinlida granules	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 granules	placebo prepared in indistinguishable granules

Primary Outcome Measures

Name	Time	Method
change in HbA1c levels	16 weeks

Secondary Outcome Measures

Name	Time	Method
BMI	16 weeks
blood pressures	16 weeks
fasting, postload 30-min and 2-h plasma glucose	16 weeks
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
incretins	16 weeks
metabolomic parameters	16 weeks

Trial Locations

Locations (1)

Guang Ning; 🇨🇳 Shanghai, Shanghai, China