Type 2 DiabetesPhase 1/2NCT04466904
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
A Phase 1/2 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
This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention 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
- 42 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2020to 28 May 2021
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Ketoacidosis or lactic acidosis within 6 months prior to screening.
- History of severe hypoglycaemic episodes within 6 months prior to screening.
- Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening.
- Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) > 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening.
- The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).
- 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
Administrated by subcutaneous injection
PlaceboDrug
Administrated by subcutaneous injection
DulaglutideDrug
Administrated by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBI362 low dose cohort | Experimental | Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection. Receives: Drug: IBI362; Drug: Placebo; Drug: Dulaglutide |
| IBI362 medium dose cohort | Experimental | Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection Receives: Drug: IBI362; Drug: Placebo; Drug: Dulaglutide |
| IBI362 high dose cohort | Experimental | Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection Receives: Drug: IBI362; Drug: Placebo; Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
Measured: From the first dose of study drug to week 19
Secondary outcomes (8)
The PK/PD parameters of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the Glucagon of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the Insulin of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Evaluate the C-peptide of IBI362 in patients with T2DM
Measured: From Baseline to week 12
Number of Participants With Anti-IBI362 Antibodies
Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.
Measured: From the first dose of study drug to week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start12 Sep 2020
- Primary completion28 May 2021
- Study completion28 May 2021
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT04466904
- Sponsor's protocol ID
- CIBI362A101
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x.
PubMed 35750681
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
- ClinicalTrials.gov ID
- NCT04466904
- Acronym / sponsor ID
- CIBI362A101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 10 Jul 2020 (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 trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI362 low dose cohort | Experimental | Drug: IBI362, Drug: Placebo, Drug: DulaglutideParticipants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection. |
| IBI362 medium dose cohort | Experimental | Drug: IBI362, Drug: Placebo, Drug: DulaglutideParticipants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection |
| IBI362 high dose cohort | Experimental | Drug: IBI362, Drug: Placebo, Drug: DulaglutideParticipants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Type 1 diabetes, special types of diabetes, or gestational diabetes.
- Ketoacidosis or lactic acidosis within 6 months prior to screening.
- History of severe hypoglycaemic episodes within 6 months prior to screening.
- Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening.
- Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) > 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening.
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 |
|---|---|---|
| IBI362Administrated by subcutaneous injection | Drug | IBI362 high dose cohort, IBI362 low dose cohort, IBI362 medium dose cohort |
| PlaceboAdministrated by subcutaneous injection | Drug | IBI362 high dose cohort, IBI362 low dose cohort, IBI362 medium dose cohort |
| DulaglutideAdministrated by subcutaneous injection | Drug | IBI362 high dose cohort, IBI362 low dose cohort, IBI362 medium dose cohort |
Primary outcome
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Time frame: From the first dose of study drug to week 19
Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
8 secondary outcomes
The PK/PD parameters of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Glucagon of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Insulin of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the C-peptide of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Number of Participants With Anti-IBI362 Antibodies
Time frame: From the first dose of study drug to week 19
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 23 Jul 2021.
- Derived from this study: PubMed 35750681Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x.
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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 1/2 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 0 inclusion and 6 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 23 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo (time frame: From the first dose of study drug to week 19). 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 NCT04466904, 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 23 Jul 2021.