Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus type 2; Type 2 diabetes; 10018424

• Registration Number: NL-OMON40278
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-03-08
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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%
- written informed consent

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
- Known or suspected allergy to 18F-FDG or its components

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in mean Pulse Wave Velocity (PWV) after 26 weeks between the<br /><br>Linagliptin and placebo treated group.</p><br>