ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03018665
Recruitment Status : Not yet recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Guixia Wang, 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Exenatide Drug: BIAsp30 Drug: Metformin Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2017
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exenatide and Metformin
Exenatide in Combination With Metformin
Drug: Exenatide
subcutaneous injection,5ug twice a day the first month,10ug twice a day the second and third month

Drug: Metformin
oral,0.85g,twice a day in three months

Active Comparator: BIAsp30 and Metformin
BIAsp30 in Combination With Metformin
Drug: BIAsp30
subcutaneous injection,fit dosage twice a day in three months

Drug: Metformin
oral,0.85g,twice a day in three months




Primary Outcome Measures :
  1. Rate of Inducing Diabetes Remission [ Time Frame: At the end of 12-week treatment ]
  2. Change of Rate of Maintaining Diabetes Remission [ Time Frame: 3,6,12,24,36 months after 12-week treatment ]
  3. Time of Maintaining Diabetes Remission [ Time Frame: up to 36 months after 12-week treatment ]

Secondary Outcome Measures :
  1. Change of Blood Pressure [ Time Frame: Baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  2. Change of Heart Rate [ Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  3. Change of Weight [ Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  4. Change of Waistline [ Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  5. Change of Glycosylated Hemoglobin [ Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  6. Change of Pancreatic Beta-cell Function [ Time Frame: 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.

  7. Change of Insulin Resistance Index [ Time Frame: baseline and 0,3,6,12,24,36 months after 12-week treatment ]
  8. The Incidence of Hypoglycemia [ Time Frame: During the 12-week treatment ]
  9. The Incidence of Diabetic Retinopathy [ Time Frame: up to 36 months after 12-week treatment ]
  10. The Incidence of Diabetic Nephropathy [ Time Frame: up to 36 months after 12-week treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018665


Contacts
Contact: Guixia Wang, PhD gwang168@jlu.edu.cn

Locations
China, Jilin
First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Guixia Wang, PhD       gwang168@jlu.edu.cn   
Sponsors and Collaborators
First Hospital of Jilin University
Investigators
Principal Investigator: Guixia Wang, PhD First Hospital of Jilin University

Responsible Party: Guixia Wang, Director of Endocrinology Department, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03018665     History of Changes
Other Study ID Numbers: JLUEND001
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Overweight
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Exenatide
Insulin aspart, insulin aspart protamine drug combination 30:70
Metformin
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists