A Study of IBI362 in Participants With Type 2 Diabetes
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBI362 6.0mg ①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks；③6mg, SC, once a week* 20weeks. |
Drug: IBI362
IBI362 administered subcutaneously (SC) once a week.
|
| Experimental: dulaglutide 1.5mg, SC, once a week* 28weeks |
Drug: dulaglutide
Dulaglutide administered subcutaneously (SC) once a week.
|
| Experimental: IBI362 4.0mg 2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 24weeks. |
Drug: IBI362
IBI362 administered subcutaneously (SC) once a week.
|
Outcome Measures
Primary Outcome Measures
- HbA1c change from baseline at week 28 [Baseline, 28 weeks]
Secondary Outcome Measures
- 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]
- Time to peak plasma concentration (Tmax) [Baseline to 28weeks]
- Time to peak plasma concentration (Cmax) [Baseline to 28weeks]
- area under curve (AUC) [Baseline to 28weeks]
- volume distribution (V) [Baseline to 28weeks]
- half-life (half-life, T1/2 [Baseline to 28weeks]
- clearance rate (clearance, CL) [Baseline to 28weeks]
- To assess changes in PD parameters fasting insulin at different time points before and after administration. [Baseline to 28weeks]
- To assess changes in PD parameters fasting C-peptide at different time points before and after administration. [Baseline to 28weeks]
Eligibility Criteria
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.
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | China |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI362A302