Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Type 2 Diabetes Clinical Trial

Official title:

A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466904
• Other study ID #: CIBI362A101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 12, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: July 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• IBI362
Administrated by subcutaneous injection
• Placebo
Administrated by subcutaneous injection
• Dulaglutide
Administrated by subcutaneous injection

Locations

Country	Name	City	State
China	China Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	Evaluate the Glucagon of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	Evaluate the Insulin of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	Evaluate the C-peptide of IBI362 in patients with T2DM		From Baseline to week 12
Secondary	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