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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Collaborator:
Shijiazhuang Yiling Pharmaceutical company, LTD
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT02035644
First received: January 12, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 12, 2014
January 12, 2014
February 2014
February 2015   (final data collection date for primary outcome measure)
change in HbA1c levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Dyslipidemia
  • Drug: Jinlida granules
  • Drug: placebo granules
  • 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
    Intervention: Drug: Jinlida granules
  • Placebo Comparator: placebo granules
    placebo prepared in indistinguishable granules
    Intervention: Drug: placebo granules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
360
Not Provided
February 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
Contact: Guang Ning, MD, PHD 8621-64370045 ext 665344
China
 
NCT02035644
CCEMD021
Not Provided
Guang Ning, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Shijiazhuang Yiling Pharmaceutical company, LTD
Not Provided
Shanghai Jiao Tong University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP