DRUG
dulaglutide
Dulaglutide administered subcutaneously (SC) once a week.
Status
Completed
Phase
Phase 3
Enrollment
731
Locations
1
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
Dulaglutide administered subcutaneously (SC) once a week.
DRUG
IBI362 administered subcutaneously (SC) once a week.
Timeline
First posted
Nov 7, 2022
Study start
Jan 6, 2023
Primary completion
Jan 26, 2024
Study completion
Apr 9, 2024
Results posted
Not reported
Registry updated
Aug 23, 2024
Outcomes
HbA1c change from baseline at week 28
Time frame · Baseline, 28 weeks
percent change from baseline in body weigh
Time frame · Baseline, 28 weeks
Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline
Time frame · Baseline, 28 weeks
Change from baseline in HbA1c (superiority)
Time frame · Baseline, 28 weeks
Proportion of subjects with HbA1c <7.0%
Time frame · Baseline, 28 weeks
Safety,Incidence and severity of adverse events and correlation with study drug;
Time frame · Baseline to 32weeks
Time to peak plasma concentration (Tmax)
Time frame · Baseline to 28weeks
Time to peak plasma concentration (Cmax)
Time frame · Baseline to 28weeks
area under curve (AUC)
Time frame · Baseline to 28weeks
volume distribution (V)
Time frame · Baseline to 28weeks
half-life (half-life, T1/2
Time frame · Baseline to 28weeks
Eligibility
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
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
China-Japan Friendship Hospital
Beijing, Beijin, China
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