Correlation Between Plasma- and Endothelial DPP-4 Activity
NCT02192853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-09-11
Summary
The investigators want to estimate both the endothelial and the plasma activity of dipeptidyl peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type 2 diabetes. Furthermore, the investigators want to investigate whether the current clinical dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial activity of the enzyme dipeptidyl peptidase 4.
Conditions
Interventions
- DRUG
-
sitagliptin
In randomized order: Day 1: tablet of 25 mg of sitagliptin + i.v. GLP-1 infusion Day 2: tablet of 100 mg of sitagliptin + i.v. GLP-1 infusion Day 3: tablet of 200 mg of sitagliptin + i.v. GLP-1 infusion
- DRUG
-
Day 4: placebo tablet
Sponsors & Collaborators
-
University Hospital, Gentofte, Copenhagen
lead OTHER
Principal Investigators
-
Filip K Knop, MD PhD · Gentofte Hospital
-
Tina Vilsbøll, MD DMSc · Gentofte Hospital
-
Asger Lund, MD · Gentofte Hospital
-
Camilla Andersen, Med.stud. · Gentofte Hospital
-
Jens Juul Holst, MD DMSc · Institute of biomedical sciences, University of Copenhagen
-
Emilie Skytte Andersen, Med.stud. · Gentofte Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 35 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2014-02-28
- Completion
- 2014-03-31
Countries
- Denmark
Study Locations
More Related Trials
-
A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)
NCT01582308 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Saxagliptin on Endothelial Function
NCT01319357 ·Status: COMPLETED ·Phase: PHASE3
-
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
NCT01272583 ·Status: COMPLETED ·Phase: NA
-
DPP-4 Inhibition, Incretins and Islet Function
NCT02089438 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
NCT03169959 ·Status: COMPLETED ·Phase: PHASE1
-
Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes
NCT02015299 ·Status: COMPLETED ·Phase: PHASE3
-
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
NCT03359590 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Sitagliptin on Incretin Effect in Patients With Type 2 Diabetes Mellitus
NCT00551590 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes
NCT01901861 ·Status: COMPLETED ·Phase: NA
-
Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
NCT01100125 ·Status: COMPLETED ·Phase: PHASE4
-
Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
NCT01937598 ·Status: COMPLETED ·Phase: PHASE3
-
Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes
NCT01334229 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy
NCT01859793 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
NCT00832390 ·Status: COMPLETED ·Phase: PHASE4
-
Saxagliptin and Atherosclerosis
NCT01552018 ·Status: COMPLETED ·Phase: PHASE4
-
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
NCT00095056 ·Status: COMPLETED ·Phase: PHASE3
-
Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis
NCT00683735 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
NCT01449747 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
NCT00127192 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes
NCT00660075 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of DPP4 Inhibition on Growth Hormone Secretion
NCT01701973 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
NCT02077309 ·Status: TERMINATED ·Phase: PHASE3
-
The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients
NCT05429554 ·Status: UNKNOWN
-
A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)
NCT02532855 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
NCT00716092 ·Status: COMPLETED ·Phase: PHASE2