Diabetes
Conditions
Interventions
Group 1:HR20014 (period 1), INS068 (period 2), INS062 (period 3)
Group 2:HR20014 (1st cycle), INS062 (2nd cycle), INS068 (3rd cycle)
Group 3:INS068 (first cycle), HR20014 (second cycle), INS062 (third cycle)
Group 4:INS068 (first cycle), INS062 (second cycle), HR20014 (third cycle)
Group 5:INS062 (first cycle), HR20014 (second cycle), INS068 (third cycle)
Group 6:INS062 (first cycle), INS068 (second cycle), HR20014 (third cycle)
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent prior to the activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol to complete this study. 2. Male or female, aged 18-45 at screening time (inclusive of upper and lower limits). 3. Subjects judged by the investigator to be generally healthy based on past medical history, physical examination, vital signs, laboratory tests, and electrocardiogram. 4. During screening period, male weight = 50.0 kg, female weight = 45.0 kg, body mass index (BMI) of 18.0~26.0 kg/m2 (inclusive of upper and lower limits). 5. In the oral glucose tolerance test (OGTT) during the screening period, fasting plasma glucose in veins was =3.9mmol/L and < 6.1 mmol/L; Venous plasma glucose at 2 h after glucose loading< 7.8 mmol/L ; and insulin levels were within the normal range.
Exclusion criteria
Exclusion criteria: 1. Having any of the following medical conditions or history: 1) known or suspected allergy to any component of the investigational medicinal product or related products; or a history of multiple and/or severe allergies to drugs or foods or a history of severe rapid allergic reactions. 2) having a history of hypertension or blood pressure abnormalities with clinical significance judged by the investigator. 3) severe systemic infectious diseases at 1 month prior to screening. 4) patients with history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis. 5) Patients who have suffered from serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past or existing diseases of the above systems to be unfit to participate in this study judged by the researchers. 2. Have used prescription medications, over-the-counter medications, and Chinese herbs (eye/nasal drops and creams allowed for topical application, regular vitamins, or occasional acetaminophen doses within the recommended dose) within 2 weeks prior to screening. 3. The following laboratory or auxiliary examination abnormalities exist during the screening period: 1) there are any laboratory examination results judged by the researcher as abnormal and clinically significant, or the laboratory examination results conformed to any of the following: ? hemoglobin 2 times the upper limit of normal (2 x ULN); ? total bilirubin > 2 times the upper limit of normal (2 x ULN); ? alkaline phosphatase > 2 times the upper limit of normal (2 x ULN); ? Glycosylated hemoglobin =6.5%. 2) Abnormal values with clinical significance were found in coagulation function indexes, and have the risk of thrombosis judged by researchers; 3) Hepatitis B surface antigen positive, hepatitis C antibody positive (or diagnosed as active hepatitis), syphilis antibody positive, human immunodeficiency virus antibody positive.4) The 12-lead electrocardiogram (ECG) showed abnormalities that were considered clinically significant. 4. Any of the following: 1) Received any other investigational drug or treatment within 3 months or 5 half-lives prior to screening, whichever is longer. 2) Previously participated in this clinical trial (defined as conducting randomization). 3) More than 15 grams of alcohol per day on average within one month prior to screening (15 grams of alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor); Or a positive blood alcohol test at screening; Or unwilling or unable to stop drinking during the trial. 4) Known or suspected drug abuse history or positive urine drug screening test during screening period. 5) Active smokers (average daily smoking =5 cigarettes) or non-active smokers who were unwilling or unable to stop smoking during the trial period (including the use of nicotine replacement). 6) Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood =400 mL in the 3 months prior to screening. 7) There is a risk of poor compliance and/or failure to complete the trial, including, but not limited to, evidenc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome ;Safety outcomes (adverse events, vital signs, physical examination, blood routine, urine routine, blood biochemistry, 12-lead electrocardiogram); | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed