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

Phase 4

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BIAsp30; Drug: Exenatide; Drug: Metformin

• Registration Number: NCT03018665
• Lead Sponsor: The First Hospital of Jilin University

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

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12
• Study Start: 2017-02
• Primary Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIAsp30 and Metformin	BIAsp30	BIAsp30 in Combination With Metformin
BIAsp30 and Metformin	Metformin	BIAsp30 in Combination With Metformin
Exenatide and Metformin	Exenatide	Exenatide in Combination With Metformin
Exenatide and Metformin	Metformin	Exenatide in Combination With Metformin

Primary Outcome Measures

Name	Time	Method
Rate of Inducing Diabetes Remission	At the end of 12-week treatment
Change of Rate of Maintaining Diabetes Remission	3,6,12,24,36 months after 12-week treatment
Time of Maintaining Diabetes Remission	up to 36 months after 12-week treatment

Secondary Outcome Measures

Name	Time	Method
Change of Weight	baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Waistline	baseline and 0,3,6,12,24,36 months after 12-week treatment
The Incidence of Diabetic Retinopathy	up to 36 months after 12-week treatment
Change of Insulin Resistance Index	baseline and 0,3,6,12,24,36 months after 12-week treatment
The Incidence of Hypoglycemia	During the 12-week treatment
The Incidence of Diabetic Nephropathy	up to 36 months after 12-week treatment
Change of Blood Pressure	Baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Heart Rate	baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Glycosylated Hemoglobin	baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Pancreatic Beta-cell Function	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.

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China