A Phase 2 interventional study of GZR101 and insulin degledec/insulin aspart in Type 2 Diabetes, sponsored by Gan and Lee Pharmaceuticals, USA. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Gan and Lee Pharmaceuticals, USA · Phase 2, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 153 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Gan and Lee Pharmaceuticals, USA is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GZR101 injection s.c., once daily, treat-to-target dose
Drug: GZR101
insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose
Drug: insulin degledec/insulin aspart
Once daily
Once daily or twice daily
Change in HbA1c
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
Time frame: Baseline to week 16
Change in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 16
Change from Baseline in Body Weight
Change in body weight from baseline to week 16 is presented.
Time frame: Baseline to Week 16
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Gan and Lee Pharmaceuticals, USA