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Trial · Interventional

CompletedPhase 2Registry data

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

NCTNCT04965506 (opens ClinicalTrials.gov in a new tab)Other idCIBI362A201
Open at ClinicalTrials.govAsk about this trial

Overview

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

China

Start
6 Sept 2021
Primary completion
28 Apr 2022
Completion
11 Jun 2022
First posted
16 Jul 2021
Last update posted
27 Dec 2023
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

    A Study of IBI362 in Chinese Patients With Type 2 Diabetes

    NCT04965506

    6 Sept 2021 to 11 Jun 2022

Registry summary

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

The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.

Interventions

  • IBI362Drug
  • placeboOther
  • DulaglutideOther

Arms5

  • Experimental

    IBI362 low dose

    Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.

  • Experimental

    IBI362 moderate dose

    Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.

  • Active comparator

    Dulaglutide

    Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.

  • Experimental

    IBI362 high dose

    Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.

  • Placebo comparator

    placebo

    Participants receive placebo by subcutaneous (SC) injection once a week.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The change in HbA1c from baseline to 20 weeks

    Time frame · Baseline,20 weeks

Secondary outcomes(2)

  1. Percentage of Participants Achieving HbA1c Target of <7.0%

    Time frame · Baseline,20 weeks

  2. Number of participants with treatment-related adverse events

    Time frame · Baseline,25 weeks

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 · 2024

15 results

Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.

Zhang et al. 2024Diabetes carecited by 64

PMID 37943529PMC10733643DOI 10.2337/dc23-1287PUB-37943529

Rights unknown15 results
Source linkSee results (15)

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
Inclusion Criteria: 1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999) 2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening. 3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening). 4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter Exclusion Criteria: 1. Type 1 diabetes, special types of diabetes, or gestational diabetes. 2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening. 3. History of severe hypoglycemic episodes within 6 months prior to screening. 4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.

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