- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018665
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
January 10, 2017 updated by: Guixia Wang, The First Hospital of Jilin University
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
200
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: Guixia Wang, PhD
- Email: gwang168@jlu.edu.cn
Study Locations
-
-
Jilin
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Changchun, Jilin, China, 130021
- First Hospital of Jilin University
-
Contact:
- Guixia Wang, PhD
- Email: gwang168@jlu.edu.cn
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exenatide and Metformin
Exenatide in Combination With Metformin
|
subcutaneous injection,5ug twice a day the first month,10ug twice a day the second and third month
oral,0.85g,twice a day in three months
|
Active Comparator: BIAsp30 and Metformin
BIAsp30 in Combination With Metformin
|
oral,0.85g,twice a day in three months
subcutaneous injection,fit dosage twice a day in three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Inducing Diabetes Remission
Time Frame: At the end of 12-week treatment
|
At the end of 12-week treatment
|
Change of Rate of Maintaining Diabetes Remission
Time Frame: 3,6,12,24,36 months after 12-week treatment
|
3,6,12,24,36 months after 12-week treatment
|
Time of Maintaining Diabetes Remission
Time Frame: up to 36 months after 12-week treatment
|
up to 36 months after 12-week treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Blood Pressure
Time Frame: Baseline and 0,3,6,12,24,36 months after 12-week treatment
|
Baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
Change of Heart Rate
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
Change of Weight
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
Change of Waistline
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
Change of Glycosylated Hemoglobin
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
Change of Pancreatic Beta-cell Function
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
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.
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
Change of Insulin Resistance Index
Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
|
baseline and 0,3,6,12,24,36 months after 12-week treatment
|
|
The Incidence of Hypoglycemia
Time Frame: During the 12-week treatment
|
During the 12-week treatment
|
|
The Incidence of Diabetic Retinopathy
Time Frame: up to 36 months after 12-week treatment
|
up to 36 months after 12-week treatment
|
|
The Incidence of Diabetic Nephropathy
Time Frame: up to 36 months after 12-week treatment
|
up to 36 months after 12-week treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guixia Wang, PhD, The First Hospital of Jilin University
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, 2017
Primary Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Body Weight
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Overweight
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Metformin
- Exenatide
Other Study ID Numbers
- JLUEND001
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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