Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Sponsor
Profil Institut für Stoffwechselforschung GmbH
Study ID
NCT02401880
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Linagliptin — DRUG
    22 subjects will receive Linagliptin for 30 days
  • Placebo — OTHER
    22 subjects will receive Placebo for 30 days
  • Empagliflozin — DRUG
    44 subjects will receive Empagliflozin for 60 days

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Feb 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Empagliflozin plus Linagliptin
    Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
  • Placebo Comparator: Empagliflozin plus Placebo
    Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
  • Other: Empagliflozin
    Empagliflozin 25mg will be adminstered for 30 days in T2DM patients

Primary Outcome Measure

• Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) [ Time Frame: 30 days ]

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