Trials / Unknown
UnknownNCT04373967
Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes
A Phase III,Randomized,Parallel,Open-label,Multicenter Trial to Compare the Efficacy and Safety of Liraglutide and Victoza® in Patients With Type 2 Diabetes Inadequately Controlled by Oral Metformin Alone
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 424 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Liraglutide injection is a glucagon-like peptide-1 (GLP-1) analogue that activates the cyclic adenosine monophosphate (cAMP) and mitogen-activated protein kinase (MAPK) pathway by binding to the GLP-1 receptor (GLP-1R),thus,it has physiological effects such as glucose-dependent insulin synthesis and secretion, inhibition of β-cell apoptosis, promotion of β-cell proliferation and regeneration, inhibition of glucagon secretion, reduction of food intake, delay of gastric emptying, enhancement of glucose utilization in peripheral tissues and reduction of glycogen output. Liraglutide injection,developed and marketed as Victoza® by Novo Nordisk,is indicated for the treatment of patients with type 2 diabetes and was approved by the U.S. Food and Drug Administration in 2010.This 26-week trial compares the effectivity on glycaemic control,safety and immunogenicity of liraglutide injection and Victoza® in patients with type 2 diabetes inadequately controlled by oral metformin alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Victoza®. | Patients will receive Victoza®. Both products will be provided as pen-injector. |
| DRUG | Metformin Hydrochloride | Patients who were receiving metformin prior to study will continue to receive it during the study. |
| DRUG | TQZ2451 | Patients will receive TQZ2451.Both products will be provided as pen-injector. |
Timeline
- Start date
- 2020-04-29
- Primary completion
- 2021-12-01
- Completion
- 2021-12-02
- First posted
- 2020-05-05
- Last updated
- 2020-07-08
Locations
46 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04373967. Inclusion in this directory is not an endorsement.