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

Jilin University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Exenatide; Drug: Metformin; Drug: BIAsp30

Study type: Interventional

Funder types: Other

Identifiers

NCT03018665

JLUEND001

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Exenatide and Metformin

Experimental group

Description:

Exenatide in Combination With Metformin

Treatment:

Drug: Exenatide

Drug: Metformin

BIAsp30 and Metformin

Active Comparator group

Description:

BIAsp30 in Combination With Metformin

Treatment:

Drug: Metformin

Drug: BIAsp30