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Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome

The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…

Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus

There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

perioperative intravenous insulin, GIK and GLP-1 treatment in diabetes mellitus

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion, insulin bolus regimen and…

Vitamin Deficiencies and Supplementation in Morbidly obese

The main objective is to optimize the supplementation of vitamins and minerals to prevent postoperative deficiencies after MB / RYGB or GS on the long term. We also examined whether the number of outpatient visits, blood tests, and costs can be…

Prospective evaluation of bone strength, physical activity, falls, subsequent fractures and mortality in patients presenting with a recent clinical fracture.

The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…

Reproducibility of insulin injected by needle-free jet-injection for glycaemic management in healthy volunteers

1. To compare the pharmacologic reproducibility of the rapid-acting insulin analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of…

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Study 1:1) To test the hypothesis that Liraglutide improves cardiovascular function in DM2 patients and whether the improvement is associated with redistribution of ectopic fat stores. 2) To test the hypothesis that Liraglutide activates BAT in DM2…

Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - safety and feasibility

We aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. Furthermore, we will assess whether a slow increase in dose of metformin over…

A multicenter, international, randomized, parallel group, double-blind, placebo-controlled, cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA

The primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided 95% confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy…

A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of volanesorsen Administered Subcutaneously to Patients with Familial Partial Lipodystrophy

Primary Objective:To evaluate the efficacy of volanesorsen for reduction in severity of metabolic derangement in patients with FPL with hypertriglyceridemia and uncontrolled diabetes.Secondary Objectives:To evaluate the safety and tolerability of…

A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients with High Lipoprotein(a)

Primary Objectives:-To characterize the safety and tolerability of ISIS 494372 in individual patients at escalating doses of 100, 200, and 300 mg/week-To characterize the efficacy of ISIS 494372 in lowering Lp(a) using a dose titration study design.…

Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

Novel Approach to Detect the Detailed Effects of Vildagliptin on Beta-cell
Dynamics in Patients with Early-onset Type 2 Diabetes

PrimaryThe 3 months* effect of Vildagliptin on insulin synthesis and storage capacitySecondaryThe 3 months* effect of vildagliptin on- Glucose, insulin, C-peptide levels- Hormonal axes, most importantly GLP1 and GIP and Glucagon- Body weight, body…

A randomized, double blind, cross-over trial to study the effects of adding bezafibrate to standard lipid lowering therapy on postprandial lipids in patients with Familial Dysbetalipoproteinemia

To evaluate the difference in the post fat load non HDL after an oral fatload between bezafibrate and placebo in patients with FD using standard lipid-lowering therapy

The effect of orally applied encapsulated lipids in yoghurt on satiety and food intake: a randomized single-blind study with cross-over design

To explore the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms.

A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.

To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.

MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES.

To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.

The effect of sitagliptin on brown adipose tissue and whole-body metabolism in overweight pre-diabetic men

To investigate whether STG enhances BAT activation, thereby increasing energy expenditure and combustion of TG-derived fatty acids, resulting in lowering of plasma TG levels and body weight.

Performance of the Medtronic Guardian Connect vs the Free Style Libre Flash Monitor in extreme sports conditions in subjects with diabetes

Primary objective To assess accuracy of GCCGM vs FLFM in 18 subjects with diabetes during a 6 day mountainbike tour in the AlpsSecondary objectives To assess the (differences in ) time in hypo-, normo- ,and hyperglycemia (expressed in minutes per…