Back to resultsMultiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI362
Placebo
Dulaglutide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
* Eligibility Criteria： Inclusion Criiteria:
- Male or female 18 to 75 years of age at the time of consent.
- 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.
- HbA1c 7.5% ≤ 11.0% by local laboratory at screening.
- Body mass index 20 ≤ BMI ≤ 35 kg/m2.
Exclusion Criteria:
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Ketoacidosis or lactic acidosis within 6 months prior to screening.
- History of severe hypoglycaemic episodes within 6 months prior to screening.
- 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.
- 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.
- The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
Sites / Locations
- China Japan Friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
IBI362 low dose cohort
IBI362 medium dose cohort
IBI362 high dose cohort
Arm Description
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The PK/PD parameters of IBI362 in patients with T2DM
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
Evaluate the Glucagon of IBI362 in patients with T2DM
Evaluate the Insulin of IBI362 in patients with T2DM
Evaluate the C-peptide of IBI362 in patients with T2DM
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.
Full Information
NCT ID
NCT04466904
First Posted
July 1, 2020
Last Updated
July 21, 2021
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04466904
Brief Title
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Official Title
A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI362 low dose cohort
Arm Type
Experimental
Arm Description
Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
Arm Title
IBI362 medium dose cohort
Arm Type
Experimental
Arm Description
Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Arm Title
IBI362 high dose cohort
Arm Type
Experimental
Arm Description
Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
Administrated by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administrated by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Intervention Description
Administrated by subcutaneous injection
Primary Outcome Measure Information:
Title
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Description
Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
Time Frame
From the first dose of study drug to week 19
Secondary Outcome Measure Information:
Title
The PK/PD parameters of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the Glucagon of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the Insulin of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Evaluate the C-peptide of IBI362 in patients with T2DM
Time Frame
From Baseline to week 12
Title
Number of Participants With Anti-IBI362 Antibodies
Description
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.
Time Frame
From the first dose of study drug to week 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
* Eligibility Criteria： Inclusion Criiteria:
Male or female 18 to 75 years of age at the time of consent.
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.
HbA1c 7.5% ≤ 11.0% by local laboratory at screening.
Body mass index 20 ≤ BMI ≤ 35 kg/m2.
Exclusion Criteria:
Type 1 diabetes, special types of diabetes, or gestational diabetes.
Ketoacidosis or lactic acidosis within 6 months prior to screening.
History of severe hypoglycaemic episodes within 6 months prior to screening.
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.
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.
The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
Facility Information:
Facility Name
China Japan Friendship Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35750681
Citation
Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x.
Results Reference
derived
Learn more about this trial
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
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