Active clinical trials for "Hypoglycemia"

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50 mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedure are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.

Idiopathic reactive hypoglycemia (IRH) describes a condition where recurrent episodes of symptomatic hypoglycemia occurs one to four hours after a meal, usually following meals rich in carbohydrates. Differential diagnoses to be excluded include those caused by isulinomas or bariatric surgery (dumping syndrome), or iatrogenic induced hypoglycaemia. The prevalence of IRH is not fully known. A British trial among 1136 random chosen women aged 17-50, reported that 37.9% experienced symptomatic hypoglycemia four times every month (mean value). However, not all reported symptoms attributed to a low blood glucose (BG) correlates with measured low levels of BG and a "true" hypoglycaemic episode, i.e., as defined by American Diabetes Association (ADA) when plasma BG value is < 3,9 mmol/l with or without accompanying symptoms. This was underscored in three studies from England, Canada and Denmark, in whom all reported hypoglycaemic symptoms, but in whom accompanying plasma glucose values < 3,3 mmol/l during hypoglycaemic symptoms only occurred in 23, 47 and 0% of the study subjects, respectively. The majority of those with symptoms related to IRH hence are having these symptoms without being classified as hypoglycemic according to conventional interpretations. However, a new (2005) ADA definition; relative hypoglycemia, also comprise these symptomatic cases of hypoglycemia following a plasma glucose > 3,9 mmol/l. Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved in regulating BG concentration. Explanations for IRH are centralized around increased insulin secretion/sensitivity and/or down regulated transcription of glucagon receptor or reduced glucagons sensitivity- and secretion. Others assess an overabundance of adrenaline and cortisol, witch is excreted at the nadir of the BS curve (venous plasma glucose between 3.6 and 3.9). The latter event, during which typical symptoms is characterized of anxiety, fatigue, irritability, palpitations, nervousness, tachycardia, tremor and sweat. Today, treatment is limited to dietary recommendations of eating frequent meals of moderate size, reasonably high in protein, and with a low glycaemic load. These advices keep cerebral glucose concentration stable and prohibit neuroglycopenic symptoms like hunger, dizziness, tingling, blurred vision, difficulty in thinking, and faintness. Pharmacologic attempts in treating IRH involves diazoxide, metformin, α-glucosidase inhibitor, glitazones and somatostatin, however, none of these medications are specifically indicated for the condition. Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but fermented in the colon by bacterially produced enzymes. It makes the rate of ventricular emptying increase and prolongs the bowel transit time; thus having a minimal impact on BG values. Inulin and oligofructose are composed of polymers of oligofructose having characteristic features different from other fibers because of their physiological and biochemical attributes. Found in a variety of edible fruit and vegetables, their fermentation produces short-chain fatty acids that acidify the colonic content. This stimulates selectively the growth of beneficial and potentially health-promoting bifidobacteria and reduces potential harmful colon bacteria. Acting as prebiotica, oligofructose induces changes in the colonic epithelium and in miscellaneous colonic functions, inter alia, enhances calcium and magnesium absorption, modulates endocrine as well as immune functions and affects the metabolism of lipids positively. The latter, being at a systemic level, may contribute to modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic cholesterol synthesis. FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose. However, several non-oligofructose studies, using a high-fiber diet, indicates reduced pre-prandial BG values, less hypoglycemic cases, glukosuri, total cholesterol, triglycerides, VLDL cholesterol and area under the curve (AUC) in a 24 hours measurement (every 2 hour) of BG and insulin concentration. Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20 g/day of oligofructose to be well tolerated. The various GI side effects identified include abdominal pain and bloating, flatulence and osmotic diarrhea. Despite the fact that fiber intake is proven inversely related to hypoglycemic events, possible benefits of daily FOS-supplementation have not yet been investigated systematically in persons suffering of IRH. Given the estimated high prevalence of IRH it is in our aim to: Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian study population of 414 study participants. Evaluating the effect of FOS supplementation on blood glucose variability.

Background: Hypoglycemia is a common presentation to the Emergency Department. Management has traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often times be treated as outlined above and safely discharged to home after a period of short observation in the Emergency Department. This procedure is also followed in the pre-hospital care arena, where insulin-dependent hypoglycemic patients are often treated and released. In addition to diet-control and insulin, patients with diabetes maintain outpatient euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate insulin release from pancreatic beta cells via a complex mechanism culminating in calcium influx and release of stored insulin from secretory granules within the pancreas. Whereas insulin-dependent diabetic patients are usually discharged home after establishing normal blood glucose levels, hospital admission is generally recommended in hypoglycemic patients taking oral sulfonylureas due to the long duration of effect and delayed clearance of the drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic episodes. Octreotide is a somatostatin analog that is known to suppress numerous hormones including insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports and one prospective study in healthy volunteers have demonstrated the safety and efficacy of octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based largely on the results of these studies some experts in field of toxicology have argued that administration of octreotide be standard therapy for all patients with recurrent hypoglycemic episodes who are known to be taking sulfonylureas. Purpose: Measure the difference in serum glucose and the incidence of hypoglycemia between two groups of sulfonylurea-dependent patients; a control group that receives standard therapy and an experimental group that receives standard therapy plus octreotide.

This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.

Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth. After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis. An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age. In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen. Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative. We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers. Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study. Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours. In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon treatment, IV glucose will immediately be instituted. Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is achieved and the number of hospitalization days in both groups.