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Propranolol for Impaired Awareness of Hypoglycemia in T1DM
NCT03161964Phase 2
Key facts
- Status
- Terminated
- Start
- Oct 2017
- Primary completion
- Dec 2019
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- propranolol
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, randomised, double-blind trial in type 1 diabetes mellitus (T1D) comparing Propranolol with Placebo (2 arms). Primary endpoint: Ratio of Self-reported Hypoglycemic Episodes to Total Hypoglycemic Episodes Determined by Continuous Glucose Monitoring (CGM) at 2 weeks. Started Oct 2017; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Propranolol
Propranolol 80 Mg Oral Capsule, Extended Release daily
Placebo
Matching placebo oral capsule daily
03
Who it enrols
Adults with Type 1 diabetes for >5 years and impaired awareness of hypoglycemia, HbA1c <= 9%, no recent beta-blocker use.
04
Endpoints
Primary
Ratio of Self-reported Hypoglycemic Episodes to Total Hypoglycemic Episodes Determined by Continuous Glucose Monitoring (CGM)
Secondary
Gold Questionnaire Score for Hypoglycemia Awareness
Clarke Questionnaire Score for Hypoglycemia Awareness
Pederson-Bjergaard Questionnaire Score for Hypoglycemia Awareness
Nadir Glucose Level
Hypoglycemia Duration
Blood Glucose Area Under the Curve (AUC)
Total Hypoglycemia Episodes
Total Severe Hypoglycemia Episodes
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