Type 2 DiabetesPhase 3NCT05628311
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
A Phase 3 study testing IBI362 in people with Type 2 Diabetes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2023to 9 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- placebo, IBI362
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo administered subcutaneously (SC) once a week.
IBI362Drug
IBI362 administered subcutaneously (SC) once a week.
| Study group | Role | What they receive |
|---|---|---|
| IBI362 4.0 mg | Experimental | ①2mg, subcutaneously (SC), once a week* 4weeks;
②4mg, SC, once a week* 44weeks. Receives: Drug: IBI362 |
| IBI362 6.0 mg | Experimental | ①2mg, SC, once a week* 4weeks;
②4mg, SC, once a week* 4weeks；
③6mg, SC, once a week* 40weeks. Receives: Drug: IBI362 |
| placebo | Placebo comparator | * placebo, SC, once a week* 24weeks;
* 2mg, SC, once a week* 4weeks;
* 4mg, SC, once a week* 4weeks；
* 6mg, SC, once a week* 16weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline at week 24
Measured: Baseline, 24 weeks
Secondary outcomes (10)
Proportion of subjects with HbA1c<7.0% at week 24
Measured: Baseline, 24 weeks
Safety, Incidence and severity of adverse events and correlation with study drug;
Measured: Baseline to 52 weeks
Time to peak plasma concentration (Tmax)
Measured: Baseline to 52 weeks
Time to peak plasma concentration (Cmax)
Measured: Baseline to 52 weeks
area under curve (AUC)
Measured: Baseline to 52 weeks
volume distribution (V)
Measured: Baseline to 52 weeks
half-life (half-life, T1/2)
Measured: Baseline to 52 weeks
clearance rate (clearance, CL)
Measured: Baseline to 52 weeks
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Measured: Baseline to 52 weeks
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Measured: Baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start6 Jan 2023
- Primary completion25 Oct 2023
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628311
- Sponsor's protocol ID
- CIBI362A301
- Status last verified
- Aug 2024
- First submitted
- 17 Nov 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05628311
- Acronym / sponsor ID
- CIBI362A301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI362 4.0 mg | Experimental | Drug: IBI362①2mg, subcutaneously (SC), once a week* 4weeks; ②4mg, SC, once a week* 44weeks. |
| IBI362 6.0 mg | Experimental | Drug: IBI362①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks； ③6mg, SC, once a week* 40weeks. |
| placebo | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo administered subcutaneously (SC) once a week. | Other | placebo |
| IBI362IBI362 administered subcutaneously (SC) once a week. | Drug | IBI362 4.0 mg, IBI362 6.0 mg |
Primary outcome
HbA1c change from baseline at week 24
Time frame: Baseline, 24 weeks
10 secondary outcomes
Proportion of subjects with HbA1c<7.0% at week 24
Time frame: Baseline, 24 weeks
Safety, Incidence and severity of adverse events and correlation with study drug;
Time frame: Baseline to 52 weeks
Time to peak plasma concentration (Tmax)
Time frame: Baseline to 52 weeks
Time to peak plasma concentration (Cmax)
Time frame: Baseline to 52 weeks
area under curve (AUC)
Time frame: Baseline to 52 weeks
volume distribution (V)
Time frame: Baseline to 52 weeks
half-life (half-life, T1/2)
Time frame: Baseline to 52 weeks
clearance rate (clearance, CL)
Time frame: Baseline to 52 weeks
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time frame: Baseline to 52 weeks
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time frame: Baseline to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI362 in people with Type 2 Diabetes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change from baseline at week 24 (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.