Skip to main content
OpenTrials
Completed

NCT Number: NCT06199505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GZR101

Drug

Once daily

insulin degledec/insulin aspart

Drug

Once daily or twice daily

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline to week 16

    Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment

Secondary outcomes

  1. Change in Fasting Plasma Glucose (FPG)

    Time frame: Baseline to Week 16

    Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment

  2. The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16

    Time frame: Week 16

    The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented.

  3. Incidence and Rate of hypoglycemia Events

    Time frame: 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.

  4. Incidence and Rate of Treatment-emergent AE/SAEs

    Time frame: 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.

  5. Change from baseline in ADA and Nab

    Time frame: Baseline to Week 16

    Samples from the GZR101 arm of the study were analysed for anti-drug antibodies.

Other outcomes

  1. Change from Baseline in Body Weight

    Time frame: Baseline to Week 16

    Change in body weight from baseline to week 16 is presented.

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.