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Completed

NCT Number: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China-Japan Friendship Hospital

Beijing, Beijin, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • T2D was diagnosed according to WHO standards in 1999 for
  • Age ≥ 18 when signing the informed consent form
  • After used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%.
  • BMI≥23 kg/m2 at screening.
  • Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Exclusion criteria

  • Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
  • Weight change>5% within 12 weeks before screening (chief complaint)
  • Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.
  • Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
  • There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
  • Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
  • Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
  • The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study

Treatment and study plan

Dulaglutide

Drug

Dulaglutide administered subcutaneously (SC) once a week.

IBI362

Drug

IBI362 administered subcutaneously (SC) once a week.

Primary outcomes

  1. HbA1c change from baseline at week 28

    Time frame: Baseline, 28 weeks

Secondary outcomes

  1. percent change from baseline in body weigh

    Time frame: Baseline, 28 weeks

  2. Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline

    Time frame: Baseline, 28 weeks

  3. Change from baseline in HbA1c (superiority)

    Time frame: Baseline, 28 weeks

  4. Proportion of subjects with HbA1c <7.0%

    Time frame: Baseline, 28 weeks

  5. Safety,Incidence and severity of adverse events and correlation with study drug;

    Time frame: Baseline to 32weeks

  6. Time to peak plasma concentration (Tmax)

    Time frame: Baseline to 28weeks

  7. Time to peak plasma concentration (Cmax)

    Time frame: Baseline to 28weeks

  8. area under curve (AUC)

    Time frame: Baseline to 28weeks

  9. volume distribution (V)

    Time frame: Baseline to 28weeks

  10. half-life (half-life, T1/2

    Time frame: Baseline to 28weeks

  11. clearance rate (clearance, CL)

    Time frame: Baseline to 28weeks

  12. To assess changes in PD parameters fasting insulin at different time points before and after administration.

    Time frame: Baseline to 28weeks

  13. To assess changes in PD parameters fasting C-peptide at different time points before and after administration.

    Time frame: Baseline to 28weeks

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of IBI362 Versus Dulaglutide as add-on to Metformin and/or SGLT2 Inhibitor or TZD in Subjects With Type 2 Diabetes (DREAMS-2)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
Aug 23, 2024

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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