A Study of IBI362 in Participants With Type 2 Diabetes

NCT ID: NCT05606913

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 731 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2024-04-09

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IBI362 6.0mg

①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks；③6mg, SC, once a week\* 20weeks.

Group Type: EXPERIMENTAL

IBI362

Intervention Type: DRUG

IBI362 administered subcutaneously (SC) once a week.

dulaglutide

1.5mg, SC, once a week\* 28weeks

Group Type: EXPERIMENTAL

dulaglutide

Intervention Type: DRUG

Dulaglutide administered subcutaneously (SC) once a week.

IBI362 4.0mg

2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 24weeks.

Group Type: EXPERIMENTAL

IBI362

Intervention Type: DRUG

IBI362 administered subcutaneously (SC) once a week.

Interventions

dulaglutide

Dulaglutide administered subcutaneously (SC) once a week.

Intervention Type: DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. T2D was diagnosed according to WHO standards in 1999 for

2. Age ≥ 18 when signing the informed consent form

3. 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%.

4. BMI≥23 kg/m2 at screening.

5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Exclusion Criteria

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs

2. Weight change>5% within 12 weeks before screening (chief complaint)

3. Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.

4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes

5. 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)

6. 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

7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period

8. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital

Beijing, Beijin, China

Countries

China

Other Identifiers

CIBI362A302

Identifier Type: -

Identifier Source: org_study_id