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Hypoglycemia clinical trials

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NCT ID: NCT02171130 Completed - Diabetes Mellitus Clinical Trials

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Start date: May 2014
Phase: Phase 3
Study type: Interventional

Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

NCT ID: NCT02146404 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow

Start date: August 2014
Phase: N/A
Study type: Interventional

Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen consumption and cerebral blood flow. Objective: The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se. Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical hypoglycemia unawareness. Furthermore, the investigators expect that this effect of hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow (CBF).

NCT ID: NCT02135068 Completed - Type 1 Diabetes Clinical Trials

Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

Start date: January 2015
Phase: Early Phase 1
Study type: Interventional

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

NCT ID: NCT02127541 Completed - Clinical trials for Endogenous Hyperinsulinaemic Hypoglycaemia

New Imaging Procedure for the Localisation of Insulinoma

Start date: January 6, 2014
Phase: N/A
Study type: Interventional

Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.

NCT ID: NCT02109315 Withdrawn - Clinical trials for Type 1 Diabetes Mellitus

Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.

DIAB-01
Start date: May 2014
Phase: Phase 1
Study type: Interventional

To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes of endothelial function

NCT ID: NCT02107326 Completed - Quality of Life Clinical Trials

Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in Treating Type 1 Diabetes

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life

NCT ID: NCT02086227 Completed - Hypoglycemia Clinical Trials

Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to ascertain the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford Laboratories), 1 mg (1 IU), SC in healthy adult subjects.

NCT ID: NCT02083133 Completed - Diabetes Clinical Trials

Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis

DOSE-HD
Start date: October 1, 2013
Phase:
Study type: Observational

The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.

NCT ID: NCT02081014 Completed - Hypoglycemia Clinical Trials

Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

Start date: March 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.

NCT ID: NCT02081001 Completed - Hypoglycemia Clinical Trials

PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

Start date: March 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.