BAQSIMI demonstrated comparable efficacy to injectable glucagon in adult patients with Type 1 diabetes
Treatment success for BAQSIMI and glucagon injectable*
| X-AXIS: | % Treatment Success |
| LEGEND: | blue square BAQSIMI (3 mg) grey square injectable glucagon (1 mg) |
| 98.7% | |
| 100% |
Treatment success was defined as the percentage of patients with either an increase in blood glucose to ≥3.9 mmol/L or an increase of ≥1.1 mmol/L from blood glucose nadir within 30 minutes.
Nadir is defined as minimum glucose measurement at the time of or within 10 minutes after glucagon administration. The mean nadir blood glucose was 2.5 mmol/L for BAQSIMI and 2.7 mmol/L for injectable glucagon.
* Study IGBC was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with Type 1 diabetes (n=77) that compared the efficacy of a single 3 mg dose of BAQSIMI versus 1 mg injectable glucagon for treatment of hypoglycemia induced by intravenous insulin with a target blood glucose of <2.8 mmol/L. The primary efficacy measure was the proportion of patients achieving treatment success.
BAQSIMI began raising mean plasma glucose as early as 5 minutes*
Mean plasma glucose concentrations over time with BAQSIMI
| X-AXIS: | Time (minutes) |
| Y-AXIS: | Mean glucose (mmol/L) |
| LEGEND: | blue circle BAQSIMI 3 mg (n=66) grey circle Injectable glucagon 1 mg (n=66) |
* A randomized, multicenter, crossover noninferiority trial was conducted in adult patients with Type 1 diabetes. Hypoglycemia was induced with intravenous insulin and treated by 3 mg intranasal glucagon or 1 mg intra-muscular glucagon. Plasma glucose was measured after each treatment was given.
Nasal congestion does not impact the absorption of BAQSIMI
Download the full study publication
Clinical use:
BAQSIMI has not been studied in pediatric patients less than 4 years old.
Limited clinical trial experience has not identified difference in responses between elderly (≥65 years of age) and younger patients.
Contraindications:
- Hypersensitivity to glucagon or to any ingredient in the formulation or container
- Pheochromocytoma
- Insulinoma
Most serious warnings and precautions:
Lack of response: BAQSIMI should be given only in patients where impaired consciousness precludes oral carbohydrates. After intranasal administration of BAQSIMI, the patient will normally respond within 15 minutes. If the patient does not respond within 15 minutes, intravenous glucose must be administered as soon as IV access can be established.
States of starvation, adrenal insufficiency or chronic hypoglycemia: Because glucagon is of little or no help in these cases, intravenous glucose should be used for the treatment of hypoglycemia in these conditions.
Other relevant warnings and precautions:
- Cardiovascular effects
- Driving and operating machinery
- Pheochromocytoma
- Insulinoma
- Sensitivity and resistance to glucagon
- Pregnant women
- Breast-feeding
- Pediatrics (<4 years of age)
- Geriatrics (≥65 years of age)
- Use in patients with Type 2 diabetes taking sulfonylureas
- Use with alcohol
- Monitoring and laboratory tests
For more information:
Consult the Product Monograph at
http://pi.lilly.com/ca/baqsimi-ca-pm.pdf
for additional important information relating to warnings and precautions, adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-888-545-5972.