Study on the positive effects of treatment with linagliptin on the arteries of patients with diabetes

Phase 1

• Conditions: type 2 diabetes mellitus; MedDRA version: 17.1Level: LLTClassification code 10045252Term: Type II diabetes mellitus without mention of complicationSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-005220-15-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Men and women, age 30 to 70 years, AND
- Treatment naïve type 2 diabetes, as defined as the presence of one of the following (American Diabetes Association definition:
- Fasting plasma glucose = 7.0 mmol/l, OR
- Random plasma glucose = 11.1 mmol/l, OR
- HbA1c =6,5%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Current or previous use of glycemic control medications
- Type 1 diabetes
- Gestational diabetes mellitus
- Other specific types of diabetes due to other causes
- Uncontrolled hypertension, defined as systolic blood pressure >160 or a diastolic blood pressure >100 mmHg at screening visit
- Severe dyslipidemia indicating primary dyslipidemia, defined as total cholesterol >8 mmol/l, tryglicerides >10 mmol/l of high density lipoprotein cholesterol <0.6 mmol/l
- Current use of weight loss medication or previous weight loss surgery
- History of severe gastrointestinal disease
- Clinical contraindications to DPP4-inhibitors
- Previous cardiovascular disease, defined as stable coronary artery disease or acute coronary syndrome, stroke or transient ischemic attack, peripheral artery disease
- Symptomatic heart failure, New York Heart Association (NYHA) class II-IV
- Women who are currently pregnant,planning to become pregnant,breastfeeding women, or women with child bearing potential not using appropriate contraceptive measures
- Clinically significant liver disease or hepatic function greater than 3 times upper limit of normal
- Known impaired renal function or eGFR <30 ml/min/1.73m2
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent
- Current active malignancy or in the previous 6 months
- Documented HIV infection
- Use of rifampicin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To assess whether linagliptin compared with placebo improves arterial stiffness in treatment naïve subjects with type 2 diabetes.;Secondary Objective: 2. To assess whether linagliptin compared with placebo improves blood pressure parameters, inflammatory and endothelial<br>function markers, albuminuria, and vascular inflammation in treatment naïve subjects with type 2 diabetes.<br>3. To determine whether the off-target effects on arterial stiffness blood pressure parameters, inflammatory endothelial function<br>markers and vascular inflammation are concordant with changes in glucose parameters, including HbA1c fasting plasma<br>glucose, and beta-cell and insulin sensitivity indices.;Primary end point(s): Difference in mean Pulse Wave Velocity (PWV) after 26 weeks between the Linagliptin and placebo treated group.;Timepoint(s) of evaluation of this end point: 26 weeks