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

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04466904
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: IBI362; Drug: Placebo; Drug: Dulaglutide	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
• Actual Study Start Date: Sep 12, 2020
• Actual Primary Completion Date: May 28, 2021
• Actual Study Completion Date: May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI362 low dose cohort Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.	Drug: IBI362; Administrated by subcutaneous injection; Drug: Placebo; Administrated by subcutaneous injection; Drug: Dulaglutide; Administrated by subcutaneous injection
Experimental: IBI362 medium dose cohort Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection	Drug: IBI362; Administrated by subcutaneous injection; Drug: Placebo; Administrated by subcutaneous injection; Drug: Dulaglutide; Administrated by subcutaneous injection
Experimental: IBI362 high dose cohort Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection	Drug: IBI362; Administrated by subcutaneous injection; Drug: Placebo; Administrated by subcutaneous injection; Drug: Dulaglutide; Administrated by subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. 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

1. The PK/PD parameters of IBI362 in patients with T2DM [From Baseline to week 12]

2. Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM [From Baseline to week 12]

3. Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM [From Baseline to week 12]

4. Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM [From Baseline to week 12]

5. Evaluate the Glucagon of IBI362 in patients with T2DM [From Baseline to week 12]

6. Evaluate the Insulin of IBI362 in patients with T2DM [From Baseline to week 12]

7. Evaluate the C-peptide of IBI362 in patients with T2DM [From Baseline to week 12]

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Japan Friendship Hospital	Beijing		China

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04466904
• Other Study ID Numbers: CIBI362A101
• First Posted: Jul 10, 2020
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Dulaglutide

Study Results

No Results Posted as of Jul 23, 2021