A Study of IBI362 in Participants With Type 2 Diabetes

NCT05606913 | Completed Phase 3

• 1 other identifier: CIBI362A302
• Study Type: interventional
• Target: 731
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline at week 28

  Baseline, 28 weeks

Secondary Outcomes (13)

• percent change from baseline in body weigh

  Baseline, 28 weeks

• Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline

  Baseline, 28 weeks

• Change from baseline in HbA1c (superiority)

  Baseline, 28 weeks

• Proportion of subjects with HbA1c <7.0%

  Baseline, 28 weeks

• Safety,Incidence and severity of adverse events and correlation with study drug;

  Baseline to 32weeks

Study Arms (3)

IBI362 6.0mg

EXPERIMENTAL

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

Drug: IBI362

dulaglutide

EXPERIMENTAL

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

Drug: dulaglutide

IBI362 4.0mg

EXPERIMENTAL

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

Drug: IBI362

Interventions

dulaglutide DRUG

Dulaglutide administered subcutaneously (SC) once a week.

dulaglutide

IBI362 DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 4.0mg; IBI362 6.0mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijin, 100029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; mazdutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 7, 2022
• Study Start: January 6, 2023
• Primary Completion: January 26, 2024
• Study Completion: April 9, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

CN (1)