Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGGZR101
Once daily
DRUGinsulin degledec/insulin aspart
Once daily or twice daily
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
* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. * BMI = 18.5-35 kg/m2 (inclusive) at screening. * Diagnosed with type 2 diabetes mellitus for ≥ 6 months. * 7.0% ≤ HbA1c ≤ 11.0% at screening.
Exclusion criteria
* Women in pregnancy or lactation. * Subjects with any malignancy diagnosed prior to screening or documented history of malignancy. * Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma. * Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening. * Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening. * Known or suspected hypersensitivity to trial product(s). * Participation in a clinical study of another study drug within 1 month prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline to week 16 | Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Baseline to Week 16 | Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment |
| The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16 | Week 16 | The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented. |
| Incidence and Rate of Treatment-emergent AE/SAEs | Baseline to Week 16 | A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. |
| Change from baseline in ADA and Nab | Baseline to Week 16 | Samples from the GZR101 arm of the study were analysed for anti-drug antibodies. |
| Incidence and Rate of hypoglycemia Events | Baseline to Week 16 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Body Weight | Baseline to Week 16 | Change in body weight from baseline to week 16 is presented. |
Countries
China
Outcome results
None listed