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CompletedNCT05628311Updated Aug 20, 2024

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

A Phase 3 interventional study of placebo and IBI362 in Type 2 Diabetes, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
319
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 319 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 197 studies on the registry; 46 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Browse Innovent Biologics (Suzhou) Co. Ltd. studies →All Innovent Biologics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
319 participants (actual)

Study arms

  • Experimental
    IBI362 4.0 mg

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

    Drug: IBI362

  • Experimental
    IBI362 6.0 mg

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

    Drug: IBI362

  • 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.

    Other: placebo

Interventions

  • Otherplacebo

    placebo administered subcutaneously (SC) once a week.

  • DrugIBI362

    IBI362 administered subcutaneously (SC) once a week.

06

What researchers measure

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

07

Study locations

1 site
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Oct 2023, 9 months.

Of 430 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 9 months is below that.

Counting every sponsor, half of 510 studies reached it within 20 months; a quarter within 14 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2022
First posted
Nov 28, 2022
StartActual
Jan 6, 2023
Primary completionActual
Oct 25, 2023
CompletionActual
May 9, 2024
Last update
Aug 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05628311
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2022
Start date
Jan 6, 2023
Primary completion
Oct 25, 2023
Completion
May 9, 2024
Last update
Aug 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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