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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)

Primary Purpose

Type 2 Diabetes, Dyslipidemia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Jinlida granules

placebo granules

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Sites / Locations

Guang Ning

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jinlida granules

placebo granules

Arm Description

Jinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes

placebo prepared in indistinguishable granules

Outcomes

Primary Outcome Measures

change in HbA1c levels

Secondary Outcome Measures

fasting, postload 30-min and 2-h plasma glucose

fasting, postload 30-min and 2-h serum insulin

serum lipids

glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp

incretins

metabolomic parameters

BMI

blood pressures

Full Information

NCT ID

NCT02035644

First Posted

January 12, 2014

Last Updated

January 12, 2014

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shijiazhuang Yiling Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02035644

Brief Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shijiazhuang Yiling Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jinlida granules

Arm Type

Experimental

Arm Description

Jinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes

Arm Title

placebo granules

Arm Type

Placebo Comparator

Arm Description

placebo prepared in indistinguishable granules

Intervention Type

Drug

Intervention Name(s)

Jinlida granules

Intervention Type

Drug

Intervention Name(s)

placebo granules

Primary Outcome Measure Information:

Title

change in HbA1c levels

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

fasting, postload 30-min and 2-h plasma glucose

Time Frame

16 weeks

Title

fasting, postload 30-min and 2-h serum insulin

Time Frame

16 weeks

Title

serum lipids

Time Frame

16 weeks

Title

glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp

Time Frame

16 weeks

Title

incretins

Time Frame

16 weeks

Title

metabolomic parameters

Time Frame

16 weeks

Title

BMI

Time Frame

16 weeks

Title

blood pressures

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guang Ning, MD, PHD

Phone

8621-64370045

Ext

665344

Facility Information:

Facility Name

Guang Ning

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

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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)

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