Baqsimi™ (glucagon) nasal powder

3mg

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Severe Hypoglycemia Frequency

The mean incidence of severe hypoglycemia events in people with T1DM using insulin was approximately 1.5 events/person/year and in people with T2DM using insulin with or without oral glucose-lowering therapies was 1 event/person/year.

Detailed Information

Hypoglycemia Events in People With Type 1 Diabetes Mellitus

Frier et al. published a review that evaluated various published cohorts of people with T1DM and the frequency of severe hypoglycemia.1 

This review included 10 published studies in people with T1DM that 

  • were both prospective and retrospective in design

  • evaluated between 100 and 3813 people

  • were older than 14 years of age 

  • had a duration of follow-up between 1 week and 19 months

  • had reported mean HbA1c values of 7.3% to 10.7%

  • had severe hypoglycemia defined by the need for third party assistance or glucagon/IV glucose, and  

  • had various insulin regimens with the majority ranging from twice daily injections to 4 or more injections daily or CSII.1

Using data from a variety of published cohorts summarized in the review by Frier et al., the mean incidence of severe hypoglycemia events in people with T1DM using insulin was approximately 1.5 events per person per year (range, 0.2-3.2 events/person/year).1 

Using data from a variety of published cohorts summarized in the review by Frier et al., the prevalence of severe hypoglycemia events in people with T1DM using insulin was approximately 29% (range, 3%-46%).1

Hypoglycemia Events in People With Type 2 Diabetes Mellitus

Edridge et al. published a meta-analysis that evaluated population based studies of people with T2DM and the frequency of  hypoglycemia.2 

The meta-analysis for severe hypoglycemia included a total of 528,310 people with T2DM from 40 studies that  

  • were prospective, retrospective, cross-sectional, or a combination

  • individually evaluated between 41 and 361,210 people

  • had a reported mean age range of 55 to 73 years

  • had a duration of follow-up between 1 month and 22 years, and 

  • had a reported mean HbA1c values of 6.3% to 8.9%.2

Insulin With or Without Oral Glucose-lowering Therapies

The mean incidence of severe hypoglycemia events in people with T2DM using insulin with or without oral glucose-lowering therapies was 1 event per person per year (range, 0.00-3.69 events/person/year).2

The prevalence of severe hypoglycemia events in people with T2DM using insulin with or without oral glucose-lowering therapies was approximately 21% (range, 16%-25%).2

Sulfonylureas With or Without Other Oral Glucose-lowering Therapies (Non-insulin)

The mean incidence of severe hypoglycemia events in people with T2DM taking sulfonylureas with or without other oral glucose-lowering therapies was 0.01 events per person per year (range, 0.00-0.55 events/person/year).2 

The prevalence of severe hypoglycemia events in people with T2DM taking sulfonylureas with or without other oral glucose-lowering therapies was approximately 5% (range, 2%-7%).2

Non-sulfonylurea Oral Glucose-lowering Therapies (Non-insulin)

The mean incidence of severe hypoglycemia events in people with T2DM taking non-sulfonylurea oral glucose-lowering therapies was not able to be calculated due to insufficient data.2 

The prevalence of severe hypoglycemia events in people with T2DM taking non-sulfonylurea oral glucose-lowering therapies was approximately 5% (range, 3%-7%).2

Mixed Oral Glucose-lowering Therapies Not Further Defined (Non-insulin)

The mean incidence of severe hypoglycemia events in people with T2DM taking mixed oral glucose-lowering therapies was 0.01 events per person per year (range, 0.00-5.16 events/person/year).2

The prevalence of severe hypoglycemia events in people with T2DM taking mixed oral glucose-lowering therapies was approximately 5% (range, 2%-7%).2

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1. Frier BM. Hypoglycaemia in diabetes mellitus: epidemiology and clinical implications. Nat Rev Endocrinol. 2014;10(12):711-722. http://dx.doi.org/10.1038/nrendo.2014.170

2. Edridge CL, Dunkley AJ, Bodicoat DH, et al. Prevalence and incidence of hypoglycaemia in 532,542 people with type 2 diabetes on oral therapies and insulin: a systemic review and meta-analysis of population based studies. PLoS One. 2015;10(6):e0126427. http://dx.doi.org/10.1371/journal.pone.0126427

Glossary

CSII = continuous subcutaneous insulin infusion

HbA1c = glycated hemoglobin

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Date of Last Review: January 25, 2019

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