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A Study of IBI362 in Participants With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
dulaglutide
IBI362
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • China-Japan Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IBI362 6.0mg

dulaglutide

IBI362 4.0mg

Arm Description

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

1.5mg, SC, once a week* 28weeks

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

Outcomes

Primary Outcome Measures

HbA1c change from baseline at week 28

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2022
Last Updated
November 1, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05606913
Brief Title
A Study of IBI362 in Participants With Type 2 Diabetes
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 23, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI362 6.0mg
Arm Type
Experimental
Arm Description
①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks;③6mg, SC, once a week* 20weeks.
Arm Title
dulaglutide
Arm Type
Experimental
Arm Description
1.5mg, SC, once a week* 28weeks
Arm Title
IBI362 4.0mg
Arm Type
Experimental
Arm Description
2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 24weeks.
Intervention Type
Drug
Intervention Name(s)
dulaglutide
Intervention Description
Dulaglutide administered subcutaneously (SC) once a week.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
IBI362 administered subcutaneously (SC) once a week.
Primary Outcome Measure Information:
Title
HbA1c change from baseline at week 28
Time Frame
Baseline, 28 weeks
Secondary Outcome Measure Information:
Title
percent change from baseline in body weigh
Time Frame
Baseline, 28 weeks
Title
Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline
Time Frame
Baseline, 28 weeks
Title
Change from baseline in HbA1c (superiority)
Time Frame
Baseline, 28 weeks
Title
Proportion of subjects with HbA1c <7.0%
Time Frame
Baseline, 28 weeks
Title
Safety,Incidence and severity of adverse events and correlation with study drug;
Time Frame
Baseline to 32weeks
Title
Time to peak plasma concentration (Tmax)
Time Frame
Baseline to 28weeks
Title
Time to peak plasma concentration (Cmax)
Time Frame
Baseline to 28weeks
Title
area under curve (AUC)
Time Frame
Baseline to 28weeks
Title
volume distribution (V)
Time Frame
Baseline to 28weeks
Title
half-life (half-life, T1/2
Time Frame
Baseline to 28weeks
Title
clearance rate (clearance, CL)
Time Frame
Baseline to 28weeks
Title
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time Frame
Baseline to 28weeks
Title
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time Frame
Baseline to 28weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
baiyi yan
Phone
0512-69566088
Email
baiyi.yan@innoventbio.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenying Yang
Phone
010-84205718
Email
Ywying_1010@163.com

12. IPD Sharing Statement

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A Study of IBI362 in Participants With Type 2 Diabetes

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