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Trial · Interventional

CompletedPhase 1/2Registry data

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

NCTNCT04466904 (opens ClinicalTrials.gov in a new tab)Other idCIBI362A101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
42 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
12 Sept 2020
Primary completion
28 May 2021
Completion
28 May 2021
First posted
10 Jul 2020
Last update posted
23 Jul 2021
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 1/2

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

    NCT04466904

    12 Sept 2020 to 28 May 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • IBI362Drug
  • PlaceboDrug
  • DulaglutideDrug

Arms3

  • Experimental

    IBI362 low dose cohort

    Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.

  • Experimental

    IBI362 medium dose cohort

    Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

  • Experimental

    IBI362 high dose cohort

    Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo

    Time frame · From the first dose of study drug to week 19

    Registry description

    Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period

Secondary outcomes(8)

  1. The PK/PD parameters of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  2. Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  3. Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  4. Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  5. Evaluate the Glucagon of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  6. Evaluate the Insulin of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  7. Evaluate the C-peptide of IBI362 in patients with T2DM

    Time frame · From Baseline to week 12

  8. Number of Participants With Anti-IBI362 Antibodies

    Time frame · From the first dose of study drug to week 19

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

13 results

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.

Jiang et al. 2022Nature communicationscited by 42

PMID 35750681PMC9232612DOI 10.1038/s41467-022-31328-xPUB-35750681

CC BY13 results
Download PDFSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
\* 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.

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