Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
NCT ID: NCT06847178
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2025-03-01
2025-11-30
Brief Summary
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Detailed Description
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Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events.
The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
1. 3-week screening period,
2. 1-week run-in period (may be extended to a maximum of 8 weeks),
3. 12-week double-blind randomized, controlled intervention period,
4. 12-week switching to high-dose conversion, open-label intervention period,
5. 2-week follow-up period. For subjects with an extended run-in period, the trial duration can be up to 37 weeks.
Study Groups
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low-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 12-weeks of low-dose LC-Z300-01 randamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
Low-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
high-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
High-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Placebo
Experimental: placebo + LC-Z300-01 Subjects will receive 12-weeks of placebo radamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
Placebo twice daily in blinding
Administered placebo twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Interventions
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Placebo twice daily in blinding
Administered placebo twice-daily for 12 weeks in blinding
Low-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
High-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18.0 and 35.0 kg/m\^2 (both inclusive),
* Type 2 diabetes mellitus (as diagnosed clinically) before screening.
* hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening,
* Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;
Exclusion Criteria
* Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids),
* Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening,
* Presence or history of pancreatitis (acute or chronic) within 180 days before screening,
* Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
Chronic heart failure classified as being in New York Heart Association Class IV at screening,
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
18 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei-fen Xie, Prof.
Role: STUDY_DIRECTOR
Shanghai Changzheng Hospital
Locations
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC-Z300-01
Identifier Type: -
Identifier Source: org_study_id
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