Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Profil Institut für Stoffwechselforschung

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Empagliflozin; Other: Placebo; Drug: Linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02401880

EMLIN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 3 patient groups, including a placebo group

Empagliflozin plus Linagliptin

Active Comparator group

Description:

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

Treatment:

Drug: Linagliptin

Drug: Empagliflozin

Empagliflozin plus Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Drug: Empagliflozin

Empagliflozin

Other group

Description:

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

Treatment:

Drug: Empagliflozin