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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03018665
• Other study ID #: JLUEND001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 9, 2017
• Last updated: January 10, 2017
• Start date: February 2017

Study information

• Verified date: January 2017
• Source: First Hospital of Jilin University
• Contact: Guixia Wang, PhD
• Email: gwang168[@]jlu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight

Intervention

Drug:
• Exenatide
subcutaneous injection,5ug twice a day the first month,10ug twice a day the second and third month
• BIAsp30
subcutaneous injection,fit dosage twice a day in three months
• Metformin
oral,0.85g,twice a day in three months

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Inducing Diabetes Remission		At the end of 12-week treatment	No
Primary	Change of Rate of Maintaining Diabetes Remission		3,6,12,24,36 months after 12-week treatment	No
Primary	Time of Maintaining Diabetes Remission		up to 36 months after 12-week treatment	No
Secondary	Change of Blood Pressure		Baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Heart Rate		baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Weight		baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Waistline		baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Glycosylated Hemoglobin		baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Pancreatic Beta-cell Function	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.	baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	Change of Insulin Resistance Index		baseline and 0,3,6,12,24,36 months after 12-week treatment	No
Secondary	The Incidence of Hypoglycemia		During the 12-week treatment	Yes
Secondary	The Incidence of Diabetic Retinopathy		up to 36 months after 12-week treatment	No
Secondary	The Incidence of Diabetic Nephropathy		up to 36 months after 12-week treatment	No