NCT02401880

Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.

Detailed description

This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria. Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days. Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Linagliptin	22 subjects will receive Linagliptin for 30 days
OTHER	Placebo	22 subjects will receive Placebo for 30 days
DRUG	Empagliflozin	44 subjects will receive Empagliflozin for 60 days

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-03-30
• Last updated: 2016-02-24

Locations

2 sites across 1 country: Germany