Insulin Degludec

Insulin Degludec is indicated for the management of diabetes mellitus in adults and children:

Approved Indications:

• Type 1 Diabetes Mellitus (T1DM):
  As a long-acting basal insulin for patients requiring continuous insulin therapy, often in combination with rapid-acting insulin for prandial control.
• Type 2 Diabetes Mellitus (T2DM):
  For patients who require long-acting insulin to maintain basal glucose control, especially those inadequately controlled with oral antidiabetic drugs or other insulin regimens.

Clinically Accepted Off-Label Uses:

• Management of gestational diabetes under strict clinical supervision.
• Inpatient hyperglycemia when basal insulin coverage is necessary.

General Principles:

• Administer subcutaneously in the thigh, upper arm, or abdomen.
• Can be dosed once daily at the same time each day; timing may be flexible depending on patient lifestyle.
• Do not mix with other insulin products in the same syringe.
• Rotate injection sites to minimize lipodystrophy.

Adults:

• Initial dose: Typically 10 units once daily or individualized based on prior insulin therapy and blood glucose levels.
• Dose titration: Adjust by 2–4 units every 3–4 days based on fasting glucose monitoring.

Pediatrics (≥1 year):

• Dose individualized according to body weight, prior insulin therapy, and glucose levels.
• Frequent monitoring required during initiation and titration.

Elderly:

• Initiate cautiously at lower doses; monitor closely for hypoglycemia due to altered renal or hepatic function.

Special Populations:

• Renal Impairment: Lower initial doses may be necessary; monitor glucose closely.
• Hepatic Impairment: Start cautiously; adjust based on glucose levels.
• Transitioning from Other Insulins: Calculate total daily insulin requirement and adjust basal dose accordingly.

Insulin Degludec is an ultra-long-acting basal insulin analog designed to provide a steady, peakless insulin level over 24–42 hours. After subcutaneous injection, Degludec forms multi-hexamers that slowly release insulin monomers into circulation. It binds to insulin receptors on target cells, facilitating glucose uptake by muscle and adipose tissue and inhibiting hepatic glucose production. This results in consistent basal glycemic control with a lower risk of nocturnal hypoglycemia compared to intermediate or long-acting insulins.

• Absorption: Slowly absorbed after subcutaneous injection; peakless profile.
• Distribution: Distributed throughout extracellular fluid; minimal plasma protein binding.
• Metabolism: Metabolized in the liver and kidneys through proteolytic degradation into amino acids; no active metabolites.
• Elimination: Primarily renal; half-life approximately 25 hours.
• Onset of Action: 30–90 minutes.
• Duration of Action: >42 hours, providing stable basal insulin levels.
• Bioavailability: Approximately 70–80% subcutaneously.

• Pregnancy: Insulin is the preferred agent for glycemic control during pregnancy; Degludec has limited pregnancy data but is used under careful supervision. No teratogenic effects reported.
• Lactation: Compatible with breastfeeding; minimal transfer into breast milk. Monitor infant for signs of hypoglycemia.
• Caution: Dose adjustments may be needed based on frequent glucose monitoring during pregnancy and lactation.

• Primary Class: Antidiabetic Agent
• Subclass: Insulin analog, basal insulin, ultra-long-acting

• Known hypersensitivity to Insulin Degludec or any excipients.
• Severe hypoglycemia.
• Diabetic ketoacidosis unless used as part of treatment regimen.

• Hypoglycemia: High-risk patients include elderly, renal/hepatic impairment, or those on concomitant hypoglycemic agents.
• Allergic Reactions: Rare but serious; discontinue if severe reaction occurs.
• Fluid Retention/Heart Failure: Monitor patients receiving thiazolidinediones concurrently.
• Injection Site Reactions: Lipodystrophy may occur; rotate sites regularly.
• Monitoring: Regular blood glucose and HbA1c assessments recommended; monitor ketones if hyperglycemia persists.

Common:

• Hypoglycemia (most frequent)
• Injection site reactions: redness, swelling, itching
• Weight gain

Less Common:

• Edema
• Allergic reactions
• Lipodystrophy at injection sites

Rare/Severe:

• Severe hypoglycemia with neuroglycopenic symptoms
• Anaphylactic reactions

• Sulfonylureas, meglitinides: Increased risk of hypoglycemia.
• Beta-blockers: May mask hypoglycemia symptoms.
• Alcohol: Can potentiate or reduce hypoglycemic effect.
• Corticosteroids, thiazide diuretics: May decrease insulin effectiveness.
• CYP450: Minimal involvement; insulin is degraded proteolytically.

• Degludec recognized for ultra-long basal coverage with lower risk of nocturnal hypoglycemia.
• Guidelines emphasize individualized basal insulin regimens with flexible dosing timing.
• Recommended for T1DM and T2DM patients requiring stable basal glucose control with minimal fluctuations.

• Temperature: Store 2°C–8°C (refrigerated); do not freeze.
• Room Temperature Use: Can be kept at ≤30°C for up to 8 weeks.
• Light Protection: Keep in original pen/vial; protect from direct sunlight.
• Handling: Roll gently before use; do not shake vigorously.
• Reconstitution: Not required; solution is clear and ready-to-use.