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NCT Number: NCT06558708

A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

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.

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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

Study Site 01

Tianjin, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

GZR101 Injection

Drug

Once daily

GZR33 Injection

Drug

Once daily

insulin aspart

Drug

Once daily

Primary outcomes

  1. Change in HbA1c

    Time frame: Week 0, 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: Week 0, Week 16

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

  2. Change in 7-point SMPG profile

    Time frame: Week 0, Week 16

    Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV

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

    Time frame: 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.

  4. Incidence and Rate of hypoglycemia Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Baozhuo Wang

CONTACT

[email protected]

01056456746

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

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.

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