Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Placebo; Drug: Linagliptin; Drug: Empagliflozin

• Registration Number: NCT02401880
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin plus Placebo	Placebo	Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Empagliflozin plus Linagliptin	Linagliptin	Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Empagliflozin plus Linagliptin	Empagliflozin	Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Empagliflozin plus Placebo	Empagliflozin	Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Empagliflozin	Empagliflozin	Empagliflozin 25mg will be adminstered for 30 days in T2DM patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
• Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)	30 days

Trial Locations

Locations (2)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany

Profil Mainz GmbH & Co. KG; 🇩🇪 Mainz, Germany