A Study of IBI362 in Participants With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05606913
• Other study ID #: CIBI362A302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 6, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: November 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 731
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• dulaglutide
Dulaglutide administered subcutaneously (SC) once a week.
• IBI362
IBI362 administered subcutaneously (SC) once a week.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change from baseline at week 28		Baseline, 28 weeks
Secondary	percent change from baseline in body weigh		Baseline, 28 weeks
Secondary	Proportion of subjects with HbA1c <7.0% and weight loss =5% from baseline		Baseline, 28 weeks
Secondary	Change from baseline in HbA1c (superiority)		Baseline, 28 weeks
Secondary	Proportion of subjects with HbA1c <7.0%		Baseline, 28 weeks
Secondary	Safety,Incidence and severity of adverse events and correlation with study drug;		Baseline to 32weeks
Secondary	Time to peak plasma concentration (Tmax)		Baseline to 28weeks
Secondary	Time to peak plasma concentration (Cmax)		Baseline to 28weeks
Secondary	area under curve (AUC)		Baseline to 28weeks
Secondary	volume distribution (V)		Baseline to 28weeks
Secondary	half-life (half-life, T1/2		Baseline to 28weeks
Secondary	clearance rate (clearance, CL)		Baseline to 28weeks
Secondary	To assess changes in PD parameters fasting insulin at different time points before and after administration.		Baseline to 28weeks
Secondary	To assess changes in PD parameters fasting C-peptide at different time points before and after administration.		Baseline to 28weeks