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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02035644
Recruitment Status : Unknown
Verified January 2014 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Shijiazhuang Yiling Pharmaceutical company, LTD
Information provided by (Responsible Party):
Guang Ning, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dyslipidemia Drug: Jinlida granules Drug: placebo granules Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. change in HbA1c levels [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. fasting, postload 30-min and 2-h plasma glucose [ Time Frame: 16 weeks ]
  2. fasting, postload 30-min and 2-h serum insulin [ Time Frame: 16 weeks ]
  3. serum lipids [ Time Frame: 16 weeks ]
  4. glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp [ Time Frame: 16 weeks ]
  5. incretins [ Time Frame: 16 weeks ]
  6. metabolomic parameters [ Time Frame: 16 weeks ]
  7. BMI [ Time Frame: 16 weeks ]
  8. blood pressures [ Time Frame: 16 weeks ]

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders