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

• Status: Not yet recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospital of Jilin University; The First Hospital of Jilin University
• Treatments: Biphasic Insulins; Exenatide; Glucagon-Like Peptide 1; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane; Metformin

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.