drugset / Trial / NCT03538015

Carvedilol in Treating Hypoglycemia Unawareness

NCT03538015

Phase 2 Terminated 1 enrolled Owen Chan, PhD
RandomizedParallel-groupDouble-blindTreatment

Summary

Type 1 diabetes mellitus (T1DM) can lead to cardiovascular, renal and neurological complications if left poorly-controlled over prolonged periods of time. However, lowering glycemic goals for diabetic patients increases their risk for hypoglycemia exposure. Hypoglycemia is associated with symptoms such as heart palpitations, fatigue, shakiness, anxiety, confusion, and blurred vision. Recurrent hypoglycemia leads to impairment of the body's autonomic and symptomatic responses to this condition, and can result in loss of awareness in the patient of the hypoglycemic state. Repeated incidences of hypoglycemia from loss of this awareness can result in even more hypoglycemic episodes and more severe outcomes, such as loss of consciousness, accidents, hospitalization and even death if left untreated. The aim of this study is to investigate whether adrenergic blockade through the use of low-dose carvedilol treatment can improve hypoglycemia awareness and the counterregulatory hormone responses to hypoglycemia in T1DM patients with impaired awareness of hypoglycemia.

Timeline

Start
2019-04-22
Primary completion
2020-08-10
Completion
2020-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Carvedilol Other / unclassified 2.5 mg Oral
Subject Carvedilol Other / unclassified 3.125 mg Oral

Indications

No indication recorded.