type 2 diabetes mellitus
Conditions
Interventions
group A:sitagliptin (100mg) combined with once-daily insulin glargine
group B:twice-daily insulin aspart30
Sponsors
Nanfang Hospitai of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes (diagnostic criteria of WHO in 1999), disease course more than 12 months; insulin autoantibodies, antibodies to glutamic acid decarboxylase, islet cell antibodies were all negative; 2. Two and more than two kinds of oral hypoglycemic drugs, stable doses for more than 1 month above; 3. Aged 18 to 80 years (1) Type 2 diabetes (diagnostic criteria of WHO in 1999), disease course more than 12 months; insulin autoantibodies, antibodies to glutamic acid decarboxylase, islet cell antibodies were all negative; (2) Two and more than two kinds of oral hypoglycemic drugs, stable doses for more than 1 month above; (3) Aged 18 to 80 years, the men and women do not limit; (4) BMI 20-35kg/m2; (5) FPG>=10mmol/L,or (and) HbA1c 7-11.0%; (6) Without hypertension or bloodpressure can control below 150/90mmHg by using anti hypertension drugs; (7) The subjects are no requirements of birth, or agree to take contraceptive measures in the course of the study; (8) The subjects are not only conditional but also willing to take insulin injections; (9) Be able and willing to perform glucose monitoring; (10) Understand the process of test,Be willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patient has medical history of type 1 diabetes, diabetic ketoacidosis or evaluated for potential type 1 diabetes. The patient took either DPP-4 inhibitor (such as Sitagliptin Phosphate, Vildagliptin, Alogliptin benzoate or saxagliptin) or GLP-1 acceptor agonist (such as Exenatide or Liraglutide Acetate) at any time in the past; (2) Patient is losing weight, and not in the maintaining phase nor started weight loss drug in the past 8 weeks (such as Orlistat or Phentermine); (3) Patient underwent surgical procedure in the last 4 weeks or underwent major operation during the study; (4) Patient need or might need cortical hormone therapy constantly for >=14 days or repeated course for Pharmacological dosage; (5) Patient suffers from untreated hyperthyrosis or is being treated for hyperthyrosis; (6) Patient shows abnormal liver and kidney function: AST or ALT value>=2.5 times normal value. serum creatinine value exceeds 150umol/L or creatinine clearance rate 600mg/dL); (8) Patient is diagnosed with NYHA III or IV congestive heart-failure. Patient either experienced new symptoms of coronary heart disease or in the past 3 months: 1) Acute Coronary Syndrome (such as MI or unstable angina pectoris); 2) Coronary artery interventional therapy: Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA) or Percutaneous coronary intervention (PCI); 3) Apoplexy or Transient ischemic diseases of the nervous system; (9) Patient suffers from severe peripheral vascular diseases (such as claudication with few exercise, non-healing ischemic ulcers, diseases in need of invasive surgeries like bypass or angioplasty); (10) Patient in the condition of malignant tumor or clinical significant hemopathic diseases; (11) Pregnant or breeding women; (12) Patient with unsatisfying blood pressure: >160/100mmHg; (13) Patient with mental disorder or communication obstacle, unable to understand the study or adjustment in blood sugar monitor and treatment; (14) Uncooperative or easy to fail from follow-up or identified by investigator as having difficulty in accomplishing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood glucose;HbA1c;insulin;c-peptide;incidence of hypoglycemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| hepatic function;renal function; | — |
Countries
China
Contacts
Public ContactXue Yao-ming
Outcome results
None listed