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
  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
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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
Dyslipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 16, 2014