- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628311
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower hospital
-
Contact:
- Dalong Zhu
- Phone Number: +86-025-68182432
- Email: zhudalong@nju.edc.cn
-
Contact:
- Jiajun Zhao
- Phone Number: +86-15168889899
- Email: jjzhao@sdu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IBI362 4.0 mg
①2mg, subcutaneously (SC), once a week* 4weeks; ②4mg, SC, once a week* 44weeks. |
IBI362 administered subcutaneously (SC) once a week.
|
Experimental: IBI362 6.0 mg
①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks; ③6mg, SC, once a week* 40weeks. |
IBI362 administered subcutaneously (SC) once a week.
|
Placebo Comparator: placebo
|
placebo administered subcutaneously (SC) once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c change from baseline at week 24
Time Frame: Baseline, 24 weeks
|
Baseline, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with HbA1c<7.0% at week 24
Time Frame: Baseline, 24 weeks
|
Baseline, 24 weeks
|
Safety, Incidence and severity of adverse events and correlation with study drug;
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
Time to peak plasma concentration (Tmax)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
Time to peak plasma concentration (Cmax)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
area under curve (AUC)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
volume distribution (V)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
half-life (half-life, T1/2)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
clearance rate (clearance, CL)
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time Frame: Baseline to 52 weeks
|
Baseline to 52 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI362A301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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