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Clinical Trial Details

Trial ID: L4799
Source ID: NCT06558708
Associated Drug: Gzr101 Injection
Title: A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: GZR101 Injection|DRUG: GZR33 Injection|DRUG: Insulin aspart
Outcome Measures: Primary: Change in HbA1c, Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment, Week 0, week 16 | Secondary: Change in Fasting Plasma Glucose (FPG), Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment, 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, 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., 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., Week 0, Week 19
Sponsor/Collaborators: Sponsor: Gan and Lee Pharmaceuticals, USA
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2024-12
Results First Posted:
Last Update Posted: 2024-08-19
Locations: Study Site 01, Tianjin, China
URL: https://clinicaltrials.gov/show/NCT06558708