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
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Locations near you
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Full eligibility criteria for NCT03018665
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
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.
All locations for NCT03018665
First Hospital of Jilin University
Changchun, Jilin, China, 130021
View full eligibility
Tris trial is registered with FDA with number: NCT03018665. The sponsor of the trial is First Hospital of Jilin University and it is looking for 200 volunteers for the current phase.
Official trial 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
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