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)

January 12, 2014 updated by: Guang Ning, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guang Ning, MD, PHD
  • Phone Number: 665344 8621-64370045

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Guang Ning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in HbA1c levels
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 12, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 12, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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