Type 2 Diabetic mellitus
Conditions
Interventions
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Diagnosed with type 2 diabetes with a stable dose of any mono- or multi-oral anti-diabetes drugs except for TZDs and DPP4i at least 3 months treatment; 3. Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening; 4. HbA1c more than 7.0% and 85cm (female) or >80cm (female).
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods; 2. Diagnosis or history of: (1) Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome; (2) Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; 3. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months; 4. Triglycerides (fasting) >4.5 mmol/L (>400 mg/dL) at screening or within 4 weeks prior to screening; 5. Patients with clinically acute or chronic liver disease or characterized by ALT or AST >3x upper limit of normal (ULN) confirmed on two consecutive measurements within 4 weeks prior to screening period; 6. Patients with moderate /severe renal impairment or end-stage renal disease (CrCl less than 50 mL/min) at screening or within 4 weeks prior to screening; 7. Significant cardiovascular history within the past 3 months prior to screening defined as: congestive heart failure defined as New York Heart Association (NYHA) class III or IV; myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident; 8. History of chronic pancreatitis or idiopathic acute pancreatitis or gastrointestinal disease; 9. History of accurate and chronic thyroid diseases; 10. Diagnosed and/or treated malignancy within the past 5 years; 11. History of organ transplant or acquired immunodeficiency syndrome (AIDS); 12. History of alcohol abuse or illegal drug abuse within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abdominal visceral adipose tissue areas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fat content;glucose;insulin concentration;lipid profiles;TNF-alpha;CRP;adiponectin; | — |
Countries
China
Contacts
Public ContactCui Shiwei
Outcome results
None listed