Type 2 Diabetes
Conditions
Brief summary
This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
Interventions
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\. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol. * 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female. * 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening. * 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
Exclusion criteria
* 1.Presence or history of malignant neoplasm prior to screening. * 2.Known or suspected hypersensitivity to investigational medical product(s) or related products. * 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening. * 4.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. * 5\. Participated in another interventional clinical study within 4 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, 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) | Week 0, Week 16 | Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment |
| Change in 7-point SMPG profile | Week 0, Week 16 | Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV |
| Incidence and Rate of Treatment-emergent AE/SAEs | Week 0, Week 19 | 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 Events | Week 0, Week 19 | 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 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. |
Countries
China
Contacts
Primary ContactBaozhuo Wang
Outcome results
None listed