Back to resultsA Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Exenatide
BIAsp30
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- A signed and dated informed consent form obtained from the subject before any study related procedures take place.
- Age ≥18 years to ≤65 years at Visit 1.
- The subject has a new diagnosis of type 2 diabetes without any treatment.
- HbA1c ≥8.0% to ≤14.0% at Visit 1.
- BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
Exclusion Criteria:
- The subject has a history of type 1 diabetes or a secondary form of diabetes.
- The subject has received an anti-diabetic drug before the screening visit.
- Treatment with systemic steroids 2 months prior to screening
- Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
- The subject has a history of acute or chronic pancreatitis
- Any gastrointestinal diseases or surgeries that induce chronic malabsorption
- Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
- The subject has a history of recurrent severe hypoglycaemia.
- Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
- Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
- Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
- Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
- Known or suspected abuse of alcohol,narcotics or illicit drugs.
Sites / Locations
- First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exenatide and Metformin
BIAsp30 and Metformin
Arm Description
Exenatide in Combination With Metformin
BIAsp30 in Combination With Metformin
Outcomes
Primary Outcome Measures
Rate of Inducing Diabetes Remission
Change of Rate of Maintaining Diabetes Remission
Time of Maintaining Diabetes Remission
Secondary Outcome Measures
Change of Blood Pressure
Change of Heart Rate
Change of Weight
Change of Waistline
Change of Glycosylated Hemoglobin
Change of Pancreatic Beta-cell Function
Pancreatic Beta-cell Function will be evaluated by insulin releasing test. The fasting and 2-hour postprandial plasma glucose concentrations and serum insulin concentrations will be tested.
Change of Insulin Resistance Index
The Incidence of Hypoglycemia
The Incidence of Diabetic Retinopathy
The Incidence of Diabetic Nephropathy
Full Information
NCT ID
NCT03018665
First Posted
January 9, 2017
Last Updated
January 10, 2017
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT03018665
Brief Title
A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
Official Title
A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
Detailed Description
Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exenatide and Metformin
Arm Type
Experimental
Arm Description
Exenatide in Combination With Metformin
Arm Title
BIAsp30 and Metformin
Arm Type
Active Comparator
Arm Description
BIAsp30 in Combination With Metformin
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month
Intervention Type
Drug
Intervention Name(s)
BIAsp30
Intervention Description
subcutaneous injection，fit dosage twice a day in three months
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
oral，0.85g，twice a day in three months
Primary Outcome Measure Information:
Title
Rate of Inducing Diabetes Remission
Time Frame
At the end of 12-week treatment
Title
Change of Rate of Maintaining Diabetes Remission
Time Frame
3,6,12,24,36 months after 12-week treatment
Title
Time of Maintaining Diabetes Remission
Time Frame
up to 36 months after 12-week treatment
Secondary Outcome Measure Information:
Title
Change of Blood Pressure
Time Frame
Baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Heart Rate
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Weight
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Waistline
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Glycosylated Hemoglobin
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Pancreatic Beta-cell Function
Description
Pancreatic Beta-cell Function will be evaluated by insulin releasing test. The fasting and 2-hour postprandial plasma glucose concentrations and serum insulin concentrations will be tested.
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
Change of Insulin Resistance Index
Time Frame
baseline and 0,3,6,12,24,36 months after 12-week treatment
Title
The Incidence of Hypoglycemia
Time Frame
During the 12-week treatment
Title
The Incidence of Diabetic Retinopathy
Time Frame
up to 36 months after 12-week treatment
Title
The Incidence of Diabetic Nephropathy
Time Frame
up to 36 months after 12-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A signed and dated informed consent form obtained from the subject before any study related procedures take place.
Age ≥18 years to ≤65 years at Visit 1.
The subject has a new diagnosis of type 2 diabetes without any treatment.
HbA1c ≥8.0% to ≤14.0% at Visit 1.
BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
Exclusion Criteria:
The subject has a history of type 1 diabetes or a secondary form of diabetes.
The subject has received an anti-diabetic drug before the screening visit.
Treatment with systemic steroids 2 months prior to screening
Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
The subject has a history of acute or chronic pancreatitis
Any gastrointestinal diseases or surgeries that induce chronic malabsorption
Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
The subject has a history of recurrent severe hypoglycaemia.
Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.
Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
Known or suspected abuse of alcohol,narcotics or illicit drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guixia Wang, PhD
Email
gwang168@jlu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guixia Wang, PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guixia Wang, PhD
Email
gwang168@jlu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
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