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 recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2014 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Not yet recruiting
Shijiazhuang Yiling Pharmaceutical company, LTD
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine Identifier:
First received: January 12, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
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.

Condition Intervention Phase
Type 2 Diabetes
Drug: Jinlida granules
Drug: placebo granules
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • change in HbA1c levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting, postload 30-min and 2-h plasma glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • fasting, postload 30-min and 2-h serum insulin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • serum lipids [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • incretins [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • metabolomic parameters [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • blood pressures [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02035644

Contact: Guang Ning, MD, PHD 8621-64370045 ext 665344

China, Shanghai
Guang Ning Not yet recruiting
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shijiazhuang Yiling Pharmaceutical company, LTD
  More Information

Responsible Party: Guang Ning, the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Identifier: NCT02035644     History of Changes
Other Study ID Numbers: CCEMD021 
Study First Received: January 12, 2014
Last Updated: January 12, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases processed this record on May 01, 2016