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A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
placebo
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 at least 2 months Age ≥ 18 when signing the informed consent form The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening Maintain a stable diet and exercise lifestyle during the study 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) Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 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

  • Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

IBI362 4.0 mg

IBI362 6.0 mg

placebo

Arm Description

①2mg, subcutaneously (SC), once a week* 4weeks; ②4mg, SC, once a week* 44weeks.

①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks; ③6mg, SC, once a week* 40weeks.

placebo, SC, once a week* 24weeks; 2mg, SC, once a week* 4weeks; 4mg, SC, once a week* 4weeks; 6mg, SC, once a week* 16weeks.

Outcomes

Primary Outcome Measures

HbA1c change from baseline at week 24

Secondary Outcome Measures

Proportion of subjects with HbA1c<7.0% at week 24
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
November 17, 2022
Last Updated
January 27, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05628311
Brief Title
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
January 15, 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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control. The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c<8.5% or HbA1c ≥ 8.5% before randomization.

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
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI362 4.0 mg
Arm Type
Experimental
Arm Description
①2mg, subcutaneously (SC), once a week* 4weeks; ②4mg, SC, once a week* 44weeks.
Arm Title
IBI362 6.0 mg
Arm Type
Experimental
Arm Description
①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks; ③6mg, SC, once a week* 40weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo, SC, once a week* 24weeks; 2mg, SC, once a week* 4weeks; 4mg, SC, once a week* 4weeks; 6mg, SC, once a week* 16weeks.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo 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 24
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with HbA1c<7.0% at week 24
Time Frame
Baseline, 24 weeks
Title
Safety, Incidence and severity of adverse events and correlation with study drug;
Time Frame
Baseline to 52 weeks
Title
Time to peak plasma concentration (Tmax)
Time Frame
Baseline to 52 weeks
Title
Time to peak plasma concentration (Cmax)
Time Frame
Baseline to 52 weeks
Title
area under curve (AUC)
Time Frame
Baseline to 52 weeks
Title
volume distribution (V)
Time Frame
Baseline to 52 weeks
Title
half-life (half-life, T1/2)
Time Frame
Baseline to 52 weeks
Title
clearance rate (clearance, CL)
Time Frame
Baseline to 52 weeks
Title
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time Frame
Baseline to 52 weeks
Title
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time Frame
Baseline to 52 weeks

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 at least 2 months Age ≥ 18 when signing the informed consent form The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening Maintain a stable diet and exercise lifestyle during the study 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) Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 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
Qingjiang Ni
Phone
0512-69566088
Email
qingjiang.ni@innoventbio.com
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu
Phone
+86-025-68182432
Email
zhudalong@nju.edc.cn
First Name & Middle Initial & Last Name & Degree
Jiajun Zhao
Phone
+86-15168889899
Email
jjzhao@sdu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

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