A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes

Sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study ID
NCT06559722
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin Degludec/liraglutide Injection — DRUG
    Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.
  • XULTOPHY® — DRUG
    Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.

Study Details

This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes.

Key Dates

First listed
Aug 19, 2024
Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Oct 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin Degludec/liraglutide injection
    Subcutaneously (s.c., under the skin) administration once daily in combination with metformin. Dose was individually adjusted.
  • Active Comparator: XULTOPHY®
    Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.

Primary Outcome Measure

Change from baseline in HbA1c after 26 weeks of treatment [ Time Frame: Baseline, Week 26 ]

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