Type 2 DiabetesPhase 2NCT06199505
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
A Phase 2 study testing GZR101 and insulin degledec/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 and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects 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?
- GZR101 and insulin degledec/insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 12 Jul 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
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- BMI = 18.5-35 kg/m2 (inclusive) at screening.
- Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
- 7.0% ≤ HbA1c ≤ 11.0% at screening.
Who cannot join
- Women in pregnancy or lactation.
- Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
- Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
- Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
- Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
- Known or suspected hypersensitivity to trial product(s).
- Participation in a clinical study of another study drug within 1 month prior to randomization.
Trial locations and contacts
1 site in 1 country.
China1 site
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, 100000
About this study
Official title: A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin
This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- GZR101, insulin degledec/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.
GZR101Drug
Once daily
insulin degledec/insulin aspartDrug
Once daily or twice daily
| Study group | Role | What they receive |
|---|---|---|
| GZR101 | Experimental | GZR101 injection s.c., once daily, treat-to-target dose Receives: Drug: GZR101 |
| insulin degludec/insulin aspart, | Active comparator | insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose Receives: Drug: insulin degledec/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: Baseline to week 16
Secondary outcomes (5)
Change in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Measured: Baseline to Week 16
The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16
The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented.
Measured: Week 16
Incidence and Rate of hypoglycemia Events
Hypoglycaemia alert value (level 1) was defined as episodes that were 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) were defined as episodes that were 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) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery.
Measured: Baseline to Week 16
Incidence and Rate of Treatment-emergent AE/SAEs
A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
Measured: Baseline to Week 16
Change from baseline in ADA and Nab
Samples from the GZR101 arm of the study were analysed for anti-drug antibodies.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start21 Nov 2023
- Primary completion28 Jun 2024
- Study completion12 Jul 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.
- 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunyue Hao, PhD, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199505
- Sponsor's protocol ID
- GL-GZR-CH2006
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin
- ClinicalTrials.gov ID
- NCT06199505
- Acronym / sponsor ID
- GL-GZR-CH2006
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 10 Jan 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 and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR101 | Experimental | Drug: GZR101GZR101 injection s.c., once daily, treat-to-target dose |
| insulin degludec/insulin aspart, | Active comparator | Drug: insulin degledec/insulin aspartinsulin degludec/insulin aspart injection s.c., once or twice daily, 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)
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- BMI = 18.5-35 kg/m2 (inclusive) at screening.
- Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
- 7.0% ≤ HbA1c ≤ 11.0% at screening.
Key exclusion criteria (7 listed)
- Women in pregnancy or lactation.
- Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
- Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
- Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
- Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to 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 |
|---|---|---|
| GZR101Once daily | Drug | GZR101 |
| insulin degledec/insulin aspartOnce daily or twice daily | Drug | insulin degludec/insulin aspart, |
Primary outcome
Change in HbA1c
Time frame: Baseline to week 16
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
5 secondary outcomes
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 16
The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16
Time frame: Week 16
Incidence and Rate of hypoglycemia Events
Time frame: Baseline to Week 16
Incidence and Rate of Treatment-emergent AE/SAEs
Time frame: Baseline to Week 16
Change from baseline in ADA and Nab
Time frame: Baseline to Week 16
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 17 Jan 2025.
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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.
Chunyue Hao, PhD 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 and insulin degledec/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 7 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 17 Jan 2025. 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?
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?
Change in HbA1c (time frame: Baseline to 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 17 Jan 2025.