Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Empagliflozin plus Linagliptin

Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type DRUG

22 subjects will receive Linagliptin for 30 days

Empagliflozin

Intervention Type DRUG

44 subjects will receive Empagliflozin for 60 days

Empagliflozin plus Placebo

Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

22 subjects will receive Placebo for 30 days

Empagliflozin

Intervention Type DRUG

44 subjects will receive Empagliflozin for 60 days

Empagliflozin

Empagliflozin 25mg will be adminstered for 30 days in T2DM patients

Group Type OTHER

Empagliflozin

Intervention Type DRUG

44 subjects will receive Empagliflozin for 60 days

Interventions

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Linagliptin

22 subjects will receive Linagliptin for 30 days

Intervention Type DRUG

Placebo

22 subjects will receive Placebo for 30 days

Intervention Type OTHER

Empagliflozin

44 subjects will receive Empagliflozin for 60 days

Intervention Type DRUG

Other Intervention Names

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Trajenta Jardiance

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No