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)

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02035644
• Other study ID #: CCEMD021
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 12, 2014
• Last updated: January 12, 2014
• Start date: February 2014

Study information

• Verified date: January 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Guang Ning, MD, PHD
• Phone: 8621-64370045
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes

Intervention

Drug:
• Jinlida granules

• placebo granules

Locations

Country	Name	City	State
China	Guang Ning	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Shijiazhuang Yiling Pharmaceutical company, LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c levels		16 weeks	No
Secondary	fasting, postload 30-min and 2-h plasma glucose		16 weeks	No
Secondary	fasting, postload 30-min and 2-h serum insulin		16 weeks	No
Secondary	serum lipids		16 weeks	No
Secondary	glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp		16 weeks	No
Secondary	incretins		16 weeks	No
Secondary	metabolomic parameters		16 weeks	No
Secondary	BMI		16 weeks	Yes
Secondary	blood pressures		16 weeks	Yes