| Trial ID: | L6831 |
| Source ID: | NCT06199505
|
| Associated Drug: |
Gzr101
|
| Title: |
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: GZR101|DRUG: insulin degledec/insulin aspart
|
| Outcome Measures: |
Primary: Change in HbA1c, Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment, Baseline to week 16 | Secondary: Change in Fasting Plasma Glucose (FPG), Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment, 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., 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., 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., 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., Baseline to Week 16 | Other: Change from Baseline in Body Weight, Change in body weight from baseline to week 16 is presented., Baseline to Week 16
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
153
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-11-21
|
| Completion Date: |
2024-07-12
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| Results First Posted: |
|
| Last Update Posted: |
2025-01-17
|
| Locations: |
Gan & Lee Pharmaceuticals Co., Ltd, Beijing, Beijing, 100000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06199505
|
