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Efficacy and Safety of SAL067 (Fotagliptin) in Uncontrolled Type 2 Diabetes
NCT05782192Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2019
- Primary completion
- Mar 2022
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- fotagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of fotagliptin in type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. Primary endpoint: HbA1c change from baseline at week 24. Started Jun 2019; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
SAL067
SAL067 12mg once daily
Alogliptin
Alogliptin 25mg once daily
Placebo
Placebo once daily (switches to SAL067 after 24 weeks)
03
Who it enrols
Adult patients with Type 2 diabetes mellitus uncontrolled by diet and exercise (HbA1c 7.0-10.0%), BMI 19-35 kg/m2, without severe cardiovascular disease or history of pancreatitis.
04
Endpoints
Primary
HbA1c change from baseline at week 24
Secondary
HbA1c change from baseline
Fasting Plasma Glucose change from baseline
Percentage of patients with HbA1c <7.0% and HbA1c <6.5%
Percentage of patients required use of rescue therapy
Fasting c-peptide change from baseline
Insulin sensitivity change (HOMA-IS)
Pancreatic beta-cell function change (HOMA-beta)
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