A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects With T2DM

Type 2 Diabetes Clinical Trial

Official title:

A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination With Insulin

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06199505
• Other study ID #: GL-GZR-CH2006
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 27, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: Gan and Lee Pharmaceuticals, USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• GZR101
Once daily
• insulin degledec/insulin aspart
Once daily or twice daily

Locations

Country	Name	City	State
China	Gan & Lee Pharmaceuticals Co., Ltd	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Gan and Lee Pharmaceuticals, USA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Body Weight	Change in body weight from baseline to week 16 is presented.	Baseline to Week 16
Primary	Change in HbA1c	Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment	Baseline to week 16
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment	Baseline to Week 16
Secondary	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.	Week 16
Secondary	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.	Baseline to Week 16
Secondary	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.	Baseline to Week 16
Secondary	Change from baseline in ADA and Nab	Samples from the GZR101 arm of the study were analysed for anti-drug antibodies.	Baseline to Week 16