Type 2 DiabetesPhase 2NCT06558708
A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
A Phase 2 study testing GZR101 Injection, GZR33 Injection and Insulin aspart in people with Type 2 Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin. 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?
- GZR101 Injection, GZR33 Injection and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to Dec 2024
- 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
- 1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
- 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
Who cannot join
- 1.Presence or history of malignant neoplasm prior to screening.
- 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
- 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
- 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
- 5. Participated in another interventional clinical study within 4 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin
This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
- Conditions
- Type 2 Diabetes
- Being tested
- GZR101 Injection, GZR33 Injection, Insulin aspart
- 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.
GZR101 InjectionDrug
Once daily
GZR33 InjectionDrug
Once daily
Insulin aspartDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| GZR101 Injection | Experimental | Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose Receives: Drug: GZR101 Injection |
| GZR33-70 Injection | Experimental | Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose Receives: Drug: GZR33 Injection; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
Measured: Week 0, week 16
Secondary outcomes (4)
Change in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Measured: Week 0, Week 16
Change in 7-point SMPG profile
Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV
Measured: Week 0, Week 16
Incidence and Rate of Treatment-emergent AE/SAEs
A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
Measured: Week 0, Week 19
Incidence and Rate of hypoglycemia Events
Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery.
Measured: Week 0, Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start28 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558708
- Sponsor's protocol ID
- GZR101-T2D-202
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin
- ClinicalTrials.gov ID
- NCT06558708
- Acronym / sponsor ID
- GZR101-T2D-202
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Aug 2024 (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 conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR101 Injection | Experimental | Drug: GZR101 InjectionParticipants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose |
| GZR33-70 Injection | Experimental | Drug: GZR33 Injection, Drug: Insulin aspartParticipants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
- 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
Key exclusion criteria (5 listed)
- 1.Presence or history of malignant neoplasm prior to screening.
- 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
- 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
- 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
- 5. Participated in another interventional clinical study within 4 weeks prior to randomization.
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 |
|---|---|---|
| GZR101 InjectionOnce daily | Drug | GZR101 Injection |
| GZR33 InjectionOnce daily | Drug | GZR33-70 Injection |
| Insulin aspartOnce daily | Drug | GZR33-70 Injection |
Primary outcome
Change in HbA1c
Time frame: Week 0, week 16
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
4 secondary outcomes
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 16
Change in 7-point SMPG profile
Time frame: Week 0, Week 16
Incidence and Rate of Treatment-emergent AE/SAEs
Time frame: Week 0, Week 19
Incidence and Rate of hypoglycemia Events
Time frame: Week 0, Week 19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Clinical Transparency study director
Gan & Lee Pharmaceuticals.
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 GZR101 Injection, GZR33 Injection and Insulin aspart in people with Type 2 Diabetes, run by Gan and Lee Pharmaceuticals, USA 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 5 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: status not confirmed, as of the sponsor's last update on 19 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baozhuo Wang (01056456746, baozhuo.wang@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 0, week 16). 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 19 Aug 2024.