Effect of Linagliptin on TRL Metabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02280174
• Date of registration: 28/10/2014
• Prospective Registration: No
• Primary sponsor: Ministry of Public Health, Argentina
• Public title: Effect of Linagliptin on TRL Metabolism
• Scientific title: Effect of Linagliptin on Intestinal Triglyceride-rich-lipoprotein Metabolism in Type 2 Diabetic Patients
• Date of first enrolment: September 2014
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02280174
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Juan Pa Nogueira, MD/PhD

• Name: Juan Nogueira, MD/PhD
• Affiliation: Medico Moving Center Institute, Formosa, Argentina

• Name: Juan Pa Nogueira, MD/PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men from 40 to 65 years old. (excluding women because of hormonal changes in post
menopause period could be influenced lipid parameters)

- Type 2 diabetes as defined by the American Diabetes Association.

- Body mass index between 25 and 40.0 kg/m².

- Baseline glycated hemoglobin A1c (HbA1c) between 7 and 10 %.

- Patients having received stable doses of metformin for at least 3 months before
randomization.

- Non-smoker.

- Subject without cardiovascular events 6 months ago. (the treatment with lipid
lowering agents and beta blockers in this condition could be perturbed the lipids
parameters)

- Subject is informed and is consented.

- Plasma without severe dyslipidaemia: plasma triglyceride levels <4.51mmol/L (<400
mg/dl), plasma HDL levels >1.0 mmol/L (>40 mg/dl), LDL-cholesterol <5.10 mmol/L (<200
mg/dl).

Exclusion Criteria:

- Patients having received or being treated with pioglitazone, GLP-1 analogues, insulin
or anti-obesity drugs (orlistat) within the past 3 months will be excluded

- Patients taking any other hypoglycemic agent, other than metformin.

- Patients with type 1 diabetes, secondary diabetes or acute metabolic diabetic
complications will be excluded.

- Subjects will be excluded if they have cardiovascular disease (coronary heart
disease, cerebrovascular disease or peripheral arterial disease) or if they are
taking other medications known to affect lipoprotein metabolism (e.g. steroids, beta
blockers, thiazide diuretics, lipid lowering agents: (statins, fibrates, ezetimibe,
niacin), significant alcohol intake etc.).

- Subjects who are in a situation or have any condition that, in the opinion of the
investigator, may interfere with optimal participation in the study.

- Individuals with a history of mental instability, individuals who have been treated
or are being treated for severe psychiatric illness that, in the opinion of the
investigator, may interfere with optimal participation in the study.

- History of alcohol or drug abuse within the past 2 years. Patients must not take
alcohol during the study.

- Disorders of the hematologic, digestive, or central nervous systems, including
cerebrovascular disease and degenerative disease, that would limit study evaluation
or participation.

- Known impairment of renal function (serum creatinine levels > 1.7 mg/dL for men),
dysproteinemia, nephrotic syndrome, or other renal disease (24-hour urinary protein
=3 ± 1 g).

- Active or chronic hepatobiliary or hepatic disease. In addition, patients with
aspartate aminotransferase or alanine aminotransferase >2 x upper limit of the
laboratory reference range will be excluded.

- Subjects with coagulopathy, prothrombin time (PT) or partial thromboplastin time
(PTT) at Visit 1 >1.5 times control.

- Subjects with hemoglobin >2 x the lower limit of the laboratory reference range will
be excluded.

- Patients who are known to have tested positive for human immunodeficiency virus
(HIV).

- Patients who are currently enrolled in another clinical study.

- Patients who have used any investigational drug within 30 days of the first clinic
visit.

- Congestive heart failure New York Heart Association (NYHA) Class III or IV.
Uncontrolled cardiac arrhythmias within 3 months of study entry.

- Other endocrine or metabolic disease known to influence serum lipids or lipoproteins.

- known hypersensitivity or allergy to linagliptin or its excipients, metformin

- Unwillingness or language barrier precluding adequate understanding or cooperation.



Age minimum: 40 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: linagliptin

Primary Outcome(s)

Measurement of the Area Under the Curve of Plasma apoB-48 Levels During Postprandial Period (Time 0,2,4,6,8 Hours) [Time Frame: At the end of the 12-week interventions]

Secondary ID(s)

IS000586

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aix Marseille Université

Instituto de Biología y Medicina Experimental, IBYME, Buenos Aires, Argentina