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

NCT03018665 | Unknown Phase 4

• 1 other identifier: JLUEND001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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 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

• Change of Glycosylated Hemoglobin

  baseline and 0,3,6,12,24,36 months after 12-week treatment

Study Arms (2)

Exenatide and Metformin

EXPERIMENTAL

Exenatide in Combination With Metformin

Drug: Exenatide; Drug: Metformin

BIAsp30 and Metformin

ACTIVE COMPARATOR

BIAsp30 in Combination With Metformin

Drug: BIAsp30; Drug: Metformin

Interventions

Exenatide DRUG

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

Exenatide and Metformin

BIAsp30 DRUG

subcutaneous injection，fit dosage twice a day in three months

BIAsp30 and Metformin

Metformin DRUG

oral，0.85g，twice a day in three months

BIAsp30 and Metformin; Exenatide and Metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; insulin aspart, insulin aspart protamine drug combination 30:70; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Guixia Wang, PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guixia Wang, PhD

CONTACT

gwang168@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology Department

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2021
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

CN (1)