Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

NCT02401880 | Completed Phase 4

• 1 other identifier: EMLIN-001
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

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

  30 days

Study Arms (3)

Empagliflozin plus Linagliptin

ACTIVE COMPARATOR

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

Drug: Linagliptin; Drug: Empagliflozin

Empagliflozin plus Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Drug: Empagliflozin

Empagliflozin

OTHER

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

Drug: Empagliflozin

Interventions

Linagliptin DRUG

22 subjects will receive Linagliptin for 30 days

Also known as: Trajenta

Empagliflozin plus Linagliptin

Placebo OTHER

22 subjects will receive Placebo for 30 days

Empagliflozin plus Placebo

Empagliflozin DRUG

44 subjects will receive Empagliflozin for 60 days

Also known as: Jardiance

Empagliflozin; Empagliflozin plus Linagliptin; Empagliflozin plus Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject with diabetes mellitus type 2
• Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
• HbA1c 7.0%-9.9%, both inclusive
• Diabetes duration of at least 24 months)

You may not qualify if:

• History of diabetes mellitus type 1
• GFR (as calculated by the Cockcroft-Gault equation) \< 60 ml/min at Screening
• Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead

Study Sites (2)

Profil Mainz GmbH & Co. KG

Mainz, 55116, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: March 30, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

DE (2)