Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Launched by PROFIL INSTITUT FÜR STOFFWECHSELFORSCHUNG GMBH · Mar 24, 2015

Keywords

ClinConnect Summary

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 M...

Gender

ALL

Eligibility 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