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Completed

NCT Number: NCT04965506

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
  • 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.
  • Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
  • Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

Exclusion criteria

  • Type 1 diabetes, special types of diabetes, or gestational diabetes.
  • Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
  • History of severe hypoglycemic episodes within 6 months prior to screening.
  • 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.

Treatment and study plan

IBI362

Drug

IBI362 administered subcutaneously (SC) once a week.

Placebo

Other

placebo administered subcutaneously (SC) once a week.

Dulaglutide

Other

Dulaglutide administered subcutaneously (SC) once a week.

Primary outcomes

  1. The change in HbA1c from baseline to 20 weeks

    Time frame: Baseline,20 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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