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

NCT ID: NCT03018665

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide and Metformin

Exenatide in Combination With Metformin

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month

Metformin

Intervention Type: DRUG

oral，0.85g，twice a day in three months

BIAsp30 and Metformin

BIAsp30 in Combination With Metformin

Group Type: ACTIVE_COMPARATOR

BIAsp30

Intervention Type: DRUG

subcutaneous injection，fit dosage twice a day in three months

Metformin

Intervention Type: DRUG

oral，0.85g，twice a day in three months

Interventions

Exenatide

subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month

Intervention Type: DRUG

BIAsp30

subcutaneous injection，fit dosage twice a day in three months

Intervention Type: DRUG

Metformin

oral，0.85g，twice a day in three months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Guixia Wang

Director of Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guixia Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

Guixia Wang, PhD

Role: CONTACT

gwang168@jlu.edu.cn

Facility Contacts

Guixia Wang, PhD

Role: primary

gwang168@jlu.edu.cn

Other Identifiers

JLUEND001

Identifier Type: -

Identifier Source: org_study_id