Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Linagliptin; Drug: Glimepiride

• Registration Number: NCT01703286
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.

Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-01
• Results First Submitted: 2015-01-12
• Results First Submitted QC: 2015-01-12
• Last Update Submitted: 2015-01-12
• Results First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	given once daily over 28 days
Glimepiride	Placebo	given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days
Linagliptin 5mg	Placebo	given once daily over 28 days
Linagliptin 5mg	Linagliptin	given once daily over 28 days
Glimepiride	Glimepiride	given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	baseline and day 28 for each treatment arm	Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	baseline and day 28 for each treatment arm	Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	baseline and day 28 for each treatment arm	Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Number of Patients With Adverse Events	up to 20 weeks	Number of patients with any adverse events

Trial Locations

Locations (1)

1218.105.001 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany