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NCT05606913
A Study of IBI362 in Participants With Type 2 Diabetes
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 720
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Location: China
Summary
This trial is conducted in China.
The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.
Eligibility Criteria
Inclusion Criteria:T2D was diagnosed according to WHO standards in 1999 forAge ≥ 18 when signing the informed consent formAfter used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%.BMI≥23 kg/m2 at screening.Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocolExclusion Criteria:Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugsWeight change>5% within 12 weeks before screening (chief complaint)Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetesThere 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 studyPregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study periodThe 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
Source: ClinicalTrials.gov (NCT05606913). StuddyBuddy aggregates publicly available trial information.