Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4 inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Glimepiride; Linagliptin

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes (HbA1c: 6.5-9.0% DCCT or 48-75 mmol/mol IFCC)

• Metformin monotherapy; using a stable dose for at least 3 months prior to inclusion

• Both genders (females must be post-menopausal)

• Caucasian

• Age: 35-75 years

• Body Mass Index: >25 kg/m2

• All patients with previously diagnosed hypertension should use a RAS-interfering agent (angiotensin converting enzyme inhibitor/angiotensin II receptor blocker) for at least 3 months

Exclusion Criteria:

• Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study

• Chronic use of NSAIDs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications. However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing

• Pregnancy

• Frequent occurrence of (confirmed) hypoglycemia (plasma glucose <3.9 mmol/L)

• Estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)

• Current urinary tract infection and active nephritis

• Recent (<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder

• Complaints compatible with or established gastroparesis and/or neurogenic bladder

• Active liver disease

• History of or actual pancreatic disease

• History of or actual malignancy (except for basal cell carcinoma)

• History of or actual severe mental disease

• Substance abuse (alcohol: defined as >4 units/day; smoking/nicotine: defined as daily smoking/use)

• Allergy to any of the agents used in the study

• Inability to understand the study protocol or give informed consent