Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Treatments: Empagliflozin; Linagliptin; Metformin

Criteria

Inclusion Criteria:

1. Male or female subject with diabetes mellitus type 2

2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months

3. HbA1c 7.0%-9.9%, both inclusive

4. Diabetes duration of at least 24 months)

Exclusion Criteria:

1. History of diabetes mellitus type 1

2. GFR (as calculated by the Cockcroft-Gault equation) < 60 ml/min at Screening

3. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening