A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: T2D was diagnosed according to WHO standards in 1999 for at least 2 months Age ≥ 18 when signing the informed consent form The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening Maintain a stable diet and exercise lifestyle during the study Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol Exclusion Criteria: Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs Weight change>5% within 12 weeks before screening (chief complaint) Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
Sites / Locations
- Nanjing Drum Tower HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IBI362 4.0 mg
IBI362 6.0 mg
placebo
①2mg, subcutaneously (SC), once a week* 4weeks; ②4mg, SC, once a week* 44weeks.
①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks; ③6mg, SC, once a week* 40weeks.
placebo, SC, once a week* 24weeks; 2mg, SC, once a week* 4weeks; 4mg, SC, once a week* 4weeks; 6mg, SC, once a week* 16weeks.