This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
GZR4 injection s.c., once-weekly, treat-to-target dose
Insulin Degludec s.c., once-daily, treat-to-target dose
Study Site 07
Wuhan, Hubei, China
Study Site 06
Changzhou, Jiangsu, China
Study Site 08
Jinan, Shandong, China
Study Site 04
Zibo, Shandong, China
Change in HbA1c
Change from baseline in HbA1c after 16 weeks of treatment
Time frame: From baseline (week 0) to week 16
Change in fasting plasma glucose(FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Time frame: From baseline (week 0) to week 16
Weekly doses of GZR4 Injection/Insulin Degludec
Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented.
Time frame: Week 15-16
Incidence and Rate of Treatment-emergent adverse events (TEAEs)
A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
Time frame: From baseline (week 0) to week 20
Incidence and Rate of hypoglycemia episodes
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 blood glucose (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.
Time frame: From baseline (week 0) to week 20
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Study Site 03
Xi’an, Shanxi, China
Study Site 02
Beijing, China
Study Site 05
Beijing, China
Study Site 01
Tianjin, China
Change in ADA of GZR4
Blood samples will be analysed for anti-GZR4 antibodies
Time frame: From baseline (week 0) to week 16
Change in Nab of GZR4
Blood samples will be analysed for Nab
Time frame: From baseline (week 0) to week 16