NCT03433248

Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES

RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: M.H.H. Kramer · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on renal physiology and biomarkers in metformin-treated T2DM patients.

Detailed description

Sodium-glucose linked transporters (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are relatively novel glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in rodents and type 1 diabetes patients. In addition, SGLT-2 inhibitors reduce, blood pressure and body weight. In rodents, SGLT-2 inhibitors also improved histopathological abnormalities associated with DKD. DPP-4 inhibitors are considered weight neutral, improve lipid profiles and slight reductions in blood pressure have been reported. To date, the potential renoprotective effects and mechanisms of SGLT-2 inhibitors and combination therapy with SGLT-2 inhibitors have not been sufficiently detailed in human type 2 diabetes. The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with an SGLT-2 inhibitor and a DPP-4 inhibitor on renal physiology and biomarkers in metformin-treated T2DM patients. 66 patients with type 2 diabetes will undergo a 16-week intervention period with 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy or 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy or 8-week gliclazide (SU derivative), followed by 8-week gliclazide intensification therapy in order to assess changes in the outcome parameters.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	EMPA/LINA 10/5 mg QD (n=22)	Once daily treatment with oral empagliflozin (Jardiance) 10 mg Once daily treatment with oral linagliptin (Tradjenta) 5 mg
DRUG	LINA/EMPA 5/10 mg QD (N=22)	Once daily treatment with oral linagliptin (Tradjenta) 5 mg Once daily treatment with oral empagliflozin (Jardiance) 10 mg
DRUG	Gliclazide 30 mg QD/BID (N=22)	Once daily or twice daily treatment with oral glicazide MR 30mg

Timeline

• Start date: 2017-11-09
• Primary completion: 2021-06-01
• Completion: 2022-09-01
• First posted: 2018-02-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: Netherlands