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)

Study Overview
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Brief Summary
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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.

Conditions
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Type 2 Diabetes, Dyslipidemia

Intervention / Treatment
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* Drug: Jinlida granules
* Drug: placebo granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of 20-70 years; diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening; HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline; 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) body mass index (BMI): 20<BMI<40 kg/m2; Exclusion Criteria: moderate or severe liver dysfunction, abnormal renal function; severe dysfunction of the heart; histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months; psychiatric disease or severe infection; pregnancy or planned pregnancy; use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months; use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months; diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes; history of malignant tumor within 5 years.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jinlida granules<br>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<br> <br> |
| Placebo Comparator: placebo granules<br>placebo prepared in indistinguishable granules | Drug: placebo granules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HbA1c levels |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| BMI |  | 16 weeks | 
| blood pressures |  | 16 weeks |