Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGGZR4 Injection
GZR4 injection s.c., once-weekly, treat-to-target dose
DRUGInsulin Degludec
Insulin Degludec s.c., once-daily, treat-to-target dose
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF) 2. Body mass index between 18.5 and 35.0 kg/m2 (both inclusive) 3. Diagnosed with type 2 diabetes mellitus above or equal to 6 months 4. 7.5% ≤ HbA1c ≤ 10.0% at screening.
Exclusion criteria
1. Female who is pregnant, breast-feeding. 2. Presence or history of malignant neoplasm prior to screening. 3. Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening. 4. Known or suspected hypersensitivity to investigational medical product(s) or related products. 5. Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening 6. History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening. 7. Participation in a clinical study of another study drug within 3 month prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From baseline (week 0) to week 16 | Change from baseline in HbA1c after 16 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma glucose(FPG) | From baseline (week 0) to week 16 | Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment |
| Weekly doses of GZR4 Injection/Insulin Degludec | Week 15-16 | Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented. |
| Incidence and Rate of Treatment-emergent adverse events (TEAEs) | From baseline (week 0) to week 20 | A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period. |
| Incidence and Rate of hypoglycemia episodes | From baseline (week 0) to week 20 | 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. |
| Change in ADA of GZR4 | From baseline (week 0) to week 16 | Blood samples will be analysed for anti-GZR4 antibodies |
| Change in Nab of GZR4 | From baseline (week 0) to week 16 | Blood samples will be analysed for Nab |
Countries
China
Outcome results
None listed