A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-11

Study Completion Date

2024-08-08

Brief Summary

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This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GZR4 Injection

GZR4 Injection + Oral Antidiabetic Drug

Group Type EXPERIMENTAL

GZR4 Injection

Intervention Type DRUG

GZR4 injection s.c., once-weekly, treat-to-target dose

Insulin Degludec

Insulin Degludec + Oral Antidiabetic Drug

Group Type ACTIVE_COMPARATOR

Insulin Degludec

Intervention Type DRUG

Insulin Degludec s.c., once-daily, treat-to-target dose

Interventions

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GZR4 Injection

GZR4 injection s.c., once-weekly, treat-to-target dose

Intervention Type DRUG

Insulin Degludec

Insulin Degludec s.c., once-daily, treat-to-target dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
2. Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
3. Diagnosed with type 2 diabetes mellitus above or equal to 6 months
4. 7.5% ≤ HbA1c ≤ 10.0% at screening.

Exclusion Criteria

1. Female who is pregnant, breast-feeding.
2. Presence or history of malignant neoplasm prior to screening.
3. Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
4. Known or suspected hypersensitivity to investigational medical product(s) or related products.
5. Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
6. 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.
7. Participation in a clinical study of another study drug within 3 month prior to randomization.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No