| Trial ID: | L2800 |
| Source ID: | NCT04466904
|
| Associated Drug: |
Ibi362
|
| Title: |
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: IBI362|DRUG: Placebo|DRUG: Dulaglutide
|
| Outcome Measures: |
Primary: To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo, Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period, From the first dose of study drug to week 19 | Secondary: The PK/PD parameters of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the Glucagon of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the Insulin of IBI362 in patients with T2DM, From Baseline to week 12|Evaluate the C-peptide of IBI362 in patients with T2DM, From Baseline to week 12|Number of Participants With Anti-IBI362 Antibodies, Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies., From the first dose of study drug to week 19
|
| Sponsor/Collaborators: |
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-09-12
|
| Completion Date: |
2021-05-28
|
| Results First Posted: |
|
| Last Update Posted: |
2021-07-23
|
| Locations: |
China Japan Friendship Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04466904
|
