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)

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes; Dyslipidemia
• Intervention / Treatment: Drug: Jinlida granules; Drug: placebo granules

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Guang Ning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Jinlida granules
Placebo Comparator: placebo granules; placebo prepared in indistinguishable granules	Drug: placebo granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in HbA1c levels	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI	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
blood pressures	16 weeks

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Shijiazhuang Yiling Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: January 12, 2014
• First Submitted That Met QC Criteria: January 12, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 12, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: CCEMD021