NCT05606913CompletedPhase 3
A Study of IBI362 in Participants With Type 2 Diabetes
Efficacy and Safety of IBI362 Versus Dulaglutide as add-on to Metformin and/or SGLT2 Inhibitor or TZD in Subjects With Type 2 Diabetes (DREAMS-2)
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 731 (actual)
- First submitted
- 19 Oct 2022
- Start date
- 6 Jan 2023
- Primary completion date
- 26 Jan 2024
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05606913
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 731
- From 6 Jan 2023 to the primary completion date, 26 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Weight 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 diabetes
Other illness
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- 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
Other
- 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
Who the study is looking for
- T2D was diagnosed according to WHO standards in 1999 for
- Age ≥ 18 when signing the informed consent form
- After 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 protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
- Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.Nature · 2026 · PMID 41407860
This page is information, not medical advice. Discuss any trial with your doctor.