Type 2 Diabetes
Conditions
Brief summary
This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).
Interventions
DRUGIBI362
Administrated by subcutaneous injection
DRUGPlacebo
Administrated by subcutaneous injection
DRUGDulaglutide
Administrated by subcutaneous injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\* Eligibility Criteria： Inclusion Criiteria: 1. Male or female 18 to 75 years of age at the time of consent. 2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months prior to screening. 3. HbA1c 7.5% ≤ 11.0% by local laboratory at screening. 4. Body mass index 20 ≤ BMI ≤ 35 kg/m2.
Exclusion criteria
1. Type 1 diabetes, special types of diabetes, or gestational diabetes. 2. Ketoacidosis or lactic acidosis within 6 months prior to screening. 3. History of severe hypoglycaemic episodes within 6 months prior to screening. 4. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening. 5. Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) \> 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening. 6. The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo | From the first dose of study drug to week 19 | Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The PK/PD parameters 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 | From the first dose of study drug to week 19 | 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. |
| Evaluate the Glucagon of IBI362 in patients with T2DM | From Baseline to week 12 | — |
Countries
China
Outcome results
None listed