Type 2 Diabetes
Conditions
Interventions
1:benaglutide plus metformin
2:biphasic insulin aspart 30 plus metformin
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily sign the informed consent; 2) Aged 18-75 years; 3) Male or non-pregnant, non-lactating females; 4) Type 2 diabetes according to the diagnostic criteria of WHO in 1999, duration 0.5-10 years; 5) BMI 21-40 kg/m2. 6. Inadequate glycaemic control: HbA1c 7.5%-11.0% (the HbA1c result within 14 days before the screening day is effect); 7. Subjects have received a stable dose (=1000mg/d) of metformin treatment for at least 2 months before screening 8. According to investigators' judgment, subjects are able and willing to obey the following perspectives: (1) During the whole study, treatment will be continued according to the requirements in the protocol; (2) Participating in regular visits, and willing to receive telephone follow-ups; (3) Female at childbearing age (and male whose partner is at childbearing age) is willing to receive effective contraceptive measures during the whole study.
Exclusion criteria
Exclusion criteria: 1)T1DM patients 2)History of intolerance or allergic reactions to or contraindication for beinaglutide / insulin aspart 30 3)Histories of severe hypoglycemia (=3 times) within 6 months before the screening 4)History of weight change over 10% for the last 3 months before the screening 5) Diabetic ketoacidosis or hyperosmolar nonketotic coma patients 6)Known to have proliferative retinopathy or maculopathy which needs an urgent treatment by the investigator's judgment 7)Hematological system diseases which maybe affect HbA1c valuesuch as: History of hemoglobinopathy, chronic anemia (male =120g/L, female =110g/L) 8) Impaired liver function, with obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT/AST levels =3.0 times of the upper limit of the reference range at the screening visit 9)History of transplant, renal dialysis, or serum creatinine =1.5mg/dl (133 umol/L) for male, =1.4mg/dl (124umol/L) for female 10)History of obstructive bowel disease; history of pancreatitis; family history of medullary thyroid carcinoma 11)Occurring any of the following cardiovascular diseases within three months before the screening visit: acute myocardial infarction, heart function classification III/IV according to New York Heart Association, congestive heart failure with left ventricular ejection fraction =40%, or cerebrovascular events (apoplexy) 12) Persistent uncontrolled hypertension (systolic blood pressure =180mmHg, or diastolic blood pressure =105mmHg) 13)Patients with the following diseases: vestibular diseases, malignant tumors, active tuberculosis; 14) Stress state as surgery, acute craniocerebral injury etc; 15)Use of weight loss drugs within 3 months before the screening, including but not limited to prescription drugs or herbal medicines 16)Receiving gastrointestinal disease treatment with drugs that directly affect gastrointestinal motility (such as metoclopramide, cisapride, and macrolide antibiotics) 17)Receiving long-term (>2 weeks) systemic glucocorticoid treatment (not including focal or inhalation treatment) or received this type of treatment within 2 weeks before the screening visit 18)Any conditions which may affect patients follow and complete the study protocol (as known drug abuse, alcoholic, mental diseases) 19)Currently in a study or just quit a study involving the investigational medicinal product or not approved drugs or instruments within 30 days before enrollment; or participating other types of clinical studies at the same time and not suitable to participate in this study judged by investigators from medical or science perspectives 20)Subjects who previously withdrew from this trial or other GLP-1 receptor agonist trials21)Any other cases which are deemed as inappropriate to participate in the study by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose;Postprandial Plasma Glucose;C-peptide;BMI;Body weight;waist-hip-ratio;MAGE;SDBG;ß-cell function; | — |
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Countries
China
Contacts
Public ContactLinong Ji
Peking University People's Hospital
Outcome results
None listed