Type 2 DiabetesPhase 2NCT04965506
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
A Phase 2 study testing IBI362 and Dulaglutide in people with Type 2 Diabetes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- IBI362 and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 11 Jun 2022
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
- T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.
- Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
- Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter
Who cannot join
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
- History of severe hypoglycemic episodes within 6 months prior to screening.
- Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.
Trial locations and contacts
1 site in 1 country.
China1 site
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- IBI362, placebo, Dulaglutide
- 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.
IBI362Drug
IBI362 administered subcutaneously (SC) once a week.
placeboOther
placebo administered subcutaneously (SC) once a week.
DulaglutideOther
Dulaglutide administered subcutaneously (SC) once a week.
| Study group | Role | What they receive |
|---|---|---|
| IBI362 low dose | Experimental | Participants receive low dose IBI362 by subcutaneous (SC) injection once a week. Receives: Drug: IBI362 |
| IBI362 moderate dose | Experimental | Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week. Receives: Drug: IBI362 |
| Dulaglutide | Active comparator | Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week. Receives: Other: Dulaglutide |
| IBI362 high dose | Experimental | Participants receive high dose IBI362 by subcutaneous (SC) injection once a week. Receives: Drug: IBI362 |
| placebo | Placebo comparator | Participants receive placebo by subcutaneous (SC) injection once a week. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in HbA1c from baseline to 20 weeks
Measured: Baseline,20 weeks
Secondary outcomes (2)
Percentage of Participants Achieving HbA1c Target of <7.0%
Measured: Baseline,20 weeks
Number of participants with treatment-related adverse events
Measured: Baseline,25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start6 Sep 2021
- Primary completion28 Apr 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 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
- NCT04965506
- Sponsor's protocol ID
- CIBI362A201
- Status last verified
- Dec 2023
- First submitted
- 15 Jul 2021
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang B, Cheng Z, Chen J, Zhang X, Liu D, Jiang H, Ma G, Wang X, Gan S, Sun J, Jin P, Yi J, Shi B, Ma J, Ye S, Wang G, Ji L, Gu X, Yu T, An P, Deng H, Li H, Li L, Ma Q, Qian L, Yang W. Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Diabetes Care. 2024 Jan 1;47(1):160-168. doi: 10.2337/dc23-1287.
PubMed 37943529
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04965506
- Acronym / sponsor ID
- CIBI362A201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 16 Jul 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBI362 low dose | Experimental | Drug: IBI362Participants receive low dose IBI362 by subcutaneous (SC) injection once a week. |
| IBI362 moderate dose | Experimental | Drug: IBI362Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week. |
| Dulaglutide | Active comparator | Other: DulaglutideParticipants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week. |
| IBI362 high dose | Experimental | Drug: IBI362Participants receive high dose IBI362 by subcutaneous (SC) injection once a week. |
| placebo | Placebo comparator | Other: placeboParticipants receive placebo by subcutaneous (SC) injection once a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
- T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.
- Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
- Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter
Key exclusion criteria (4 listed)
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
- History of severe hypoglycemic episodes within 6 months prior to screening.
- Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.
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 |
|---|---|---|
| IBI362IBI362 administered subcutaneously (SC) once a week. | Drug | IBI362 high dose, IBI362 low dose, IBI362 moderate dose |
| placeboplacebo administered subcutaneously (SC) once a week. | Other | placebo |
| DulaglutideDulaglutide administered subcutaneously (SC) once a week. | Other | Dulaglutide |
Primary outcome
The change in HbA1c from baseline to 20 weeks
Time frame: Baseline,20 weeks
2 secondary outcomes
Percentage of Participants Achieving HbA1c Target of <7.0%
Time frame: Baseline,20 weeks
Number of participants with treatment-related adverse events
Time frame: Baseline,25 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 27 Dec 2023.
- Derived from this study: PubMed 37943529Zhang B, Cheng Z, Chen J, Zhang X, Liu D, Jiang H, Ma G, Wang X, Gan S, Sun J, Jin P, Yi J, Shi B, Ma J, Ye S, Wang G, Ji L, Gu X, Yu T, An P, Deng H, Li H, Li L, Ma Q, Qian L, Yang W. Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Diabetes Care. 2024 Jan 1;47(1):160-168. doi: 10.2337/dc23-1287.
- 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 2 study testing IBI362 and Dulaglutide 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 4 inclusion and 4 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 27 Dec 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change in HbA1c from baseline to 20 weeks (time frame: Baseline,20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965506, which also lists 1 linked publication.
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 27 Dec 2023.