Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401880
• Other study ID #: EMLIN-001
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: February 23, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Linagliptin
22 subjects will receive Linagliptin for 30 days

Other:
• Placebo
22 subjects will receive Placebo for 30 days

Drug:
• Empagliflozin
44 subjects will receive Empagliflozin for 60 days

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co. KG	Mainz
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	• Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)		30 days	No