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Completed

NCT Number: NCT05628311

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control.

The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period.

Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c<8.5% or HbA1c ≥ 8.5% before randomization.

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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

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, 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 at least 2 months
  • Age ≥ 18 when signing the informed consent form
  • The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening
  • Maintain a stable diet and exercise lifestyle during the study
  • 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)
  • Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 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

Placebo

Other

placebo administered subcutaneously (SC) once a week.

IBI362

Drug

IBI362 administered subcutaneously (SC) once a week.

Primary outcomes

  1. HbA1c change from baseline at week 24

    Time frame: Baseline, 24 weeks

Secondary outcomes

  1. Proportion of subjects with HbA1c<7.0% at week 24

    Time frame: Baseline, 24 weeks

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

    Time frame: Baseline to 52 weeks

  3. Time to peak plasma concentration (Tmax)

    Time frame: Baseline to 52 weeks

  4. Time to peak plasma concentration (Cmax)

    Time frame: Baseline to 52 weeks

  5. area under curve (AUC)

    Time frame: Baseline to 52 weeks

  6. volume distribution (V)

    Time frame: Baseline to 52 weeks

  7. half-life (half-life, T1/2)

    Time frame: Baseline to 52 weeks

  8. clearance rate (clearance, CL)

    Time frame: Baseline to 52 weeks

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

    Time frame: Baseline to 52 weeks

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

    Time frame: Baseline to 52 weeks

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 28, 2022
Registry last updated
Aug 20, 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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