Clinical trial NCT05606913: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c change from baseline at week 28
timeFrame: Baseline, 28 weeks
Secondary outcomes:
measure: percent change from baseline in body weigh
timeFrame: Baseline, 28 weeks
measure: Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline
timeFrame: Baseline, 28 weeks
measure: Change from baseline in HbA1c (superiority)
timeFrame: Baseline, 28 weeks
measure: Proportion of subjects with HbA1c <7.0%
timeFrame: Baseline, 28 weeks
measure: Safety,Incidence and severity of adverse events and correlation with study drug;
timeFrame: Baseline to 32weeks
measure: Time to peak plasma concentration (Tmax)
timeFrame: Baseline to 28weeks
measure: Time to peak plasma concentration (Cmax)
timeFrame: Baseline to 28weeks
measure: area under curve (AUC)
timeFrame: Baseline to 28weeks
measure: volume distribution (V)
timeFrame: Baseline to 28weeks
measure: half-life (half-life, T1/2
timeFrame: Baseline to 28weeks
measure: clearance rate (clearance, CL)
timeFrame: Baseline to 28weeks
measure: To assess changes in PD parameters fasting insulin at different time points before and after administration.
timeFrame: Baseline to 28weeks
measure: To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
timeFrame: Baseline to 28weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijin
Study officials:
References: