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Completed

NCT Number: NCT01703286

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)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1218.105.001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetic male and female patients according to the following criteria:

Based upon a complete medical history and clinical laboratory tests

  • Age >= 18 and Age <= 65 years
  • Body mass index >= 25 <= 35 kg/m2
  • HbA1c <= 7.5%
  • Treatment with metformin (=1500 mg daily) for <= 3 months
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

For female patients of childbearing potential:

  • Use of acceptable method of contraception (Pearl-Index <1).

Exclusion criteria

  • Treatment with any glucose-lowering drug except for metformin within prior 3 months.
  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
  • Any evidence of a clinically relevant acute concomitant disease
  • History of cardiovascular disease (e.g. coronary artery disease history of acute myocard infarction or stroke, peripheral vascular disease).
  • History of major diabetic complications (e.g. nephropathy, retinopathy)
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, immunological or hormonal disorders (except: hypertension treated with angiotensin receptor blocker or angiotensin-converting-enzyme inhibitors, hyperlipidemia with statin therapy, thyroid hormone replacement therapy, all stable for at least three months prior to screening).
  • Surgery of the gastrointestinal tract (except appendectomy).
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  • History of relevant orthostatic hypotension, fainting spells or blackouts.
  • Chronic or relevant acute infections.
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
  • Participation in another trial with an investigational drug within one month prior to administration or during the trial.
  • Smoker (>= 1 cigarettes or >= 1 cigars or >= 1 pipes/day).
  • Alcohol abuse (more than 60 g/day).
  • Drug abuse.
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
  • Excessive physical activities (within one week prior to administration or during the trial).
  • Any laboratory value outside the reference range that is of clinical relevance.

Treatment and study plan

Placebo

Drug

Placebo matching Glimepiride

Linagliptin

Drug

given once daily for 28 days

Glimepiride

Drug

1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)

Primary outcomes

  1. Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28

    Time frame: 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 outcomes

  1. Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28

    Time frame: 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.

  2. Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28

    Time frame: 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.

  3. Number of Patients With Adverse Events

    Time frame: up to 20 weeks

    Number of patients with any adverse events

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Randomized, Three Period Cross Over, Double Blind, Double Dummy Study in Type 2 Diabetic Patients to Assess the Endothelial Effects of Linagliptin, Glimepiride and Placebo Therapy for 28 Days ('ENDOTHELINA')

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2012
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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