We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035644
First Posted: January 14, 2014
Last Update Posted: January 14, 2014
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.
Collaborator:
Shijiazhuang Yiling Pharmaceutical company, LTD
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
  Purpose
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 Dyslipidemia Drug: Jinlida granules Drug: placebo granules Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

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

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

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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT02035644


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

Locations
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
ClinicalTrials.gov Identifier: NCT02035644     History of Changes
Other Study ID Numbers: CCEMD021
First Submitted: January 12, 2014
First Posted: January 14, 2014
Last Update Posted: January 14, 2014
Last Verified: January 2014

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