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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT05628311 (opens ClinicalTrials.gov in a new tab)Other idCIBI362A301
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
319 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
6 Jan 2023
Primary completion
25 Oct 2023
Completion
9 May 2024
First posted
28 Nov 2022
Last update posted
20 Aug 2024
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 3

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

    NCT05628311

    6 Jan 2023 to 9 May 2024

Registry summary

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

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.

Interventions

  • placeboOther
  • IBI362Drug

Arms3

  • Experimental

    IBI362 4.0 mg

    ①2mg, subcutaneously (SC), once a week\* 4weeks; ②4mg, SC, once a week\* 44weeks.

  • Experimental

    IBI362 6.0 mg

    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks； ③6mg, SC, once a week\* 40weeks.

  • Placebo comparator

    placebo

    * placebo, SC, once a week\* 24weeks; * 2mg, SC, once a week\* 4weeks; * 4mg, SC, once a week\* 4weeks； * 6mg, SC, once a week\* 16weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c change from baseline at week 24

    Time frame · Baseline, 24 weeks

Secondary outcomes(10)

  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

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. T2D was diagnosed according to WHO standards in 1999 for at least 2 months 2. Age ≥ 18 when signing the informed consent form 3. 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 4. Maintain a stable diet and exercise lifestyle during the study 5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol Exclusion Criteria: 1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. Weight change\>5% within 12 weeks before screening (chief complaint) 3. Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening 4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes 5. 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) 6. 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 7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period 8. 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

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