Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.)
Age is 18-75 years
Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months
Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose.
Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed.
Systemic or intra-articular corticosteroids treatment within the last 3 months.
You may not be if
Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products
Severe hypoglycemia during the previous 6 months.
Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months.
Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association \[NYHA\] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack.
Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer.
Clareo Health | A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
