Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGExenatide
subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month
DRUGBIAsp30
subcutaneous injection，fit dosage twice a day in three months
DRUGMetformin
oral，0.85g，twice a day in three months
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change of Waistline | 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. |
| Change of Blood Pressure | 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 Retinopathy | up to 36 months after 12-week treatment | — |
| The Incidence of Diabetic Nephropathy | 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 | — |
| Change of Heart Rate | baseline and 0,3,6,12,24,36 months after 12-week treatment | — |
| Change of Weight | baseline and 0,3,6,12,24,36 months after 12-week treatment | — |
Countries
China
Contacts
Primary ContactGuixia Wang, PhD
Outcome results
None listed