Trials / Completed
CompletedNCT02106104
Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes
A Phase 4, Monocenter, Randomized, Double-blind, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Linagliptin Versus the Sulfonylurea (SU) Derivative Glimepiride on Renal Physiology and Biomarkers in Metformin-treated Patients With Type 2 Diabetes Mellitus (T2DM)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Amsterdam UMC, location VUmc · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors (DPP-4i), may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes. Therefore, the present study aims to explore the mechanistic and clinical effects of DPP-4i on fasting and postprandial renal physiology and biomarkers in patients with type 2 diabetes. Forty-eight patients with type 2 diabetes will undergo an eight week intervention with linagliptin or glimepiride in order to assess changes in the outcome parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linagliptin 5 mg QD (N=24) | Linagliptin 5 mg will be taken orally, once daily for 8 weeks |
| DRUG | Glimepiride 1 mg QD (N=24) | Glimepiride 1 mg will be taken orally, once daily for 8 weeks |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2014-04-08
- Last updated
- 2016-05-17
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02106104. Inclusion in this directory is not an endorsement.