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)
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedJanuary 14, 2014
January 1, 2014
1 year
January 12, 2014
January 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
change in HbA1c levels
16 weeks
Secondary Outcomes (8)
fasting, postload 30-min and 2-h plasma glucose
16 weeks
fasting, postload 30-min and 2-h serum insulin
16 weeks
serum lipids
16 weeks
glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp
16 weeks
incretins
16 weeks
- +3 more secondary outcomes
Study Arms (2)
Jinlida granules
EXPERIMENTALJinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes
placebo granules
PLACEBO COMPARATORplacebo prepared in indistinguishable granules
Interventions
Eligibility Criteria
You may qualify if:
- age of 20-70 years;
- diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
- HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline;
- 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)
- body mass index (BMI): 20\<BMI\<40 kg/m2;
You may not qualify if:
- moderate or severe liver dysfunction, abnormal renal function;
- severe dysfunction of the heart;
- histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
- psychiatric disease or severe infection;
- pregnancy or planned pregnancy;
- use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
- use of chronic (\>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
- diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
- history of malignant tumor within 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guang Ning
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital
Study Record Dates
First Submitted
January 12, 2014
First Posted
January 14, 2014
Study Start
February 1, 2014
Primary Completion
February 1, 2015
Last Updated
January 14, 2014
Record last verified: 2014-01