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COMPLETEDPHASE2

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

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

NCT06199505•Gan and Lee Pharmaceuticals, USA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 21, 2023

Primary Completion Date

June 28, 2024

Completion Date

July 12, 2024

Last Updated

January 17, 2025

Enrollment

153

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

GZR101

DRUG

insulin degledec/insulin aspart

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D