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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTonghua Dongbao Pharmaceutical Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Subjects who voluntarily participate in this clinical trial and signed the informed consent form (ICF);

Chinese subjects aged 18-75 years (both inclusive) at the time of consent, male or female;

Type 2 diabetes mellitus (clinically diagnosed for more than 6 months);

HbA1c7.0-10.0 % (both inclusive) by central laboratory analysis at the time of screening;

Disqualifiers

Subjects with diabetes of other types than T2DM;

Known or suspected hypersensitivity to trial product(s) or related components;

Participated in any clinical trial and Receipt of any treatment of investigational medicinal product (IMP) or medical device within 90 days prior screening;

Treatment with glucose lowering agent(s) other than stated in the inclusion criteria 5 for cumulatively more than 14 days in a period of 90 days before screening; or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy of glycemic control (Judged by the investigator);

Trial design

Treatments tested in this trial

  • Insulin Degludec/liraglutide Injection
  • XULTOPHY®

Treatment groups

510 Participants
are divided into 2 treatment groups

Locations

This trial has no locations