Clinical trial NCT03018665: 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
Official title: A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Rate of Inducing Diabetes Remission
timeFrame: At the end of 12-week treatment
measure: Change of Rate of Maintaining Diabetes Remission
timeFrame: 3,6,12,24,36 months after 12-week treatment
measure: Time of Maintaining Diabetes Remission
timeFrame: up to 36 months after 12-week treatment
Secondary outcomes:
measure: Change of Blood Pressure
timeFrame: Baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Heart Rate
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Weight
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Waistline
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Glycosylated Hemoglobin
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Pancreatic Beta-cell Function
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Insulin Resistance Index
timeFrame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: The Incidence of Hypoglycemia
timeFrame: During the 12-week treatment
measure: The Incidence of Diabetic Retinopathy
timeFrame: up to 36 months after 12-week treatment
measure: The Incidence of Diabetic Nephropathy
timeFrame: up to 36 months after 12-week treatment
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Guixia Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: