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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: IBI362; Drug: Placebo; Drug: Dulaglutide

• Registration Number: NCT04466904
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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).

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Study Start: 2020-09-12
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI362 low dose cohort	Placebo	Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
IBI362 medium dose cohort	IBI362	Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362 high dose cohort	Placebo	Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362 medium dose cohort	Placebo	Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362 high dose cohort	IBI362	Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362 low dose cohort	IBI362	Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
IBI362 low dose cohort	Dulaglutide	Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
IBI362 medium dose cohort	Dulaglutide	Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
IBI362 high dose cohort	Dulaglutide	Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Glucagon 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 Insulin 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 Area under the plasma concentration versus time curve (AUC) 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

Trial Locations

Locations (1)

China Japan Friendship Hospital; 🇨🇳 Beijing, China