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
Study Details
Study Description
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 |
|---|---|---|
| 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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- 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 Insulin Resistance Index [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A signed and dated informed consent form obtained from the subject before any study related procedures take place.
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Age ≥18 years to ≤65 years at Visit 1.
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The subject has a new diagnosis of type 2 diabetes without any treatment.
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HbA1c ≥8.0% to ≤14.0% at Visit 1.
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BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
Exclusion Criteria:
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The subject has a history of type 1 diabetes or a secondary form of diabetes.
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The subject has received an anti-diabetic drug before the screening visit.
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Treatment with systemic steroids 2 months prior to screening
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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.
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The subject has a history of acute or chronic pancreatitis
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Any gastrointestinal diseases or surgeries that induce chronic malabsorption
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Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
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The subject has a history of recurrent severe hypoglycaemia.
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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.
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Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
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Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
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Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
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Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
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Known or suspected abuse of alcohol,narcotics or illicit drugs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
Sponsors and Collaborators
- The First Hospital of Jilin University
Investigators
- Principal Investigator: Guixia Wang, PhD, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JLUEND001