Abstract
The aim of the current study (Clinical trial reg. no. NCT02715193, clinicaltrials.gov) was to study the efficacy and safety of REMD-477, a glucagon receptor antagonist, in type 1 diabetes. This was a randomized controlled trial in which 21 patients with type 1 diabetes were enrolled. Glycaemic control and insulin use were evaluated in outpatient and inpatient settings, before and after a single 70-mg dose of REMD-477 (half-life 7-10 days) or placebo. Inpatient insulin use was 26% (95% CI, 47%, 4%) lower 1 day after dosing with REMD-477 than with placebo (P = .02). Continuous glucose monitoring during post-treatment days 6 to 12 showed that average daily glucose was 27 mg/dL lower (P < .001), percent time-in-target-range (70-180 mg/dL) was ~25% greater (~3.5 h/d) (P = .001), and percent time-in-hyperglycaemic-range (> 180 mg/dL) was ~40% lower (~4 h/d) (P = .001) in the REMD-477 group than in the placebo group, without a difference in percent time-in-hypoglycaemic-range (<70 mg/dL). No serious adverse events were reported. Glucagon receptor antagonism decreases insulin requirements and improves glycaemic control in patients with type 1 diabetes.
Keywords:
diabetes; glucose homeostasis; glycaemic control, insulin.
© 2017 John Wiley & Sons Ltd.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Antibodies, Blocking / administration & dosage
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Antibodies, Blocking / adverse effects
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Antibodies, Blocking / therapeutic use
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal / adverse effects
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Monoclonal, Humanized
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Blood Glucose / analysis
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Diabetes Mellitus, Type 1 / blood
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Diabetes Mellitus, Type 1 / drug therapy*
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Diabetes Mellitus, Type 1 / metabolism
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Double-Blind Method
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Drug Administration Schedule
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Drug Therapy, Combination
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Drugs, Investigational / adverse effects
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Drugs, Investigational / therapeutic use
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Female
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Humans
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Hyperglycemia / prevention & control*
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Hypoglycemia / chemically induced
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Hypoglycemia / prevention & control*
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Hypoglycemic Agents / administration & dosage
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Hypoglycemic Agents / adverse effects
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Hypoglycemic Agents / therapeutic use*
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Injections, Subcutaneous
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Insulin / administration & dosage*
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Insulin / therapeutic use
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Male
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Monitoring, Ambulatory
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Proof of Concept Study
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Receptors, Glucagon / antagonists & inhibitors*
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Receptors, Glucagon / metabolism
Substances
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Antibodies, Blocking
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Blood Glucose
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Drugs, Investigational
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Hypoglycemic Agents
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Insulin
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Receptors, Glucagon
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volagidemab
Associated data
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ClinicalTrials.gov/NCT02715193