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Sniffy Insulin and Lizard Spit. New Diabetes Medications. Hilary Suzawa & Anoop Agrawal September 2008. Money! Money! Money!. Diabetic drug market $15 billion today Expected to be $25 billion in 2011 Cost $1500-2000 per year per patient for the new medications. Normal Physiology.

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new diabetes medications

Sniffy Insulin and Lizard Spit

New Diabetes Medications

Hilary Suzawa & Anoop Agrawal

September 2008

money money money
Money! Money! Money!
  • Diabetic drug market $15 billion today
  • Expected to be $25 billion in 2011
  • Cost $1500-2000 per year per patient for the new medications
normal physiology
Normal Physiology
  • Throughout the day, especially between meals, we rely upon hepatic glucose production to sustain normal glucose levels.
  • When you eat a meal, an insulin surge occurs in order to deal with the glucose load and deposit it into tissues – known as ‘insulin demand.’
  • To keep the incoming glucose load in balance with the endogenous glucose production, the liver needs to be suppressed.
normal physiology4
Normal Physiology
  • It’s more than just insulin – it’s glucagon that suppresses the liver’s production!
  • Also, an oral glucose load stimulates higher insulin secretion than an equal or higher IV glucose load…
  • …So, something in the GI tract is stimulating the pancreas to increase serum insulin, suppressing glucagon release
what could it be
What could it be???
  • It’s the other hormones known as the Incretins!
  • Incretin hormones are peptide hormones secreted by enteroendocrine cells (the L cells) that line the small intestine.
  • The incretins stimulate the β-cell of the pancreas.
  • Stimulate glucose-dependentinsulin secretion
    • Increase insulin in response to meals
    • Lower risk of hypoglycemia
  • Suppresses inappropriate glucagon secretion by α-cells
  • Increases β-cell growth and replication, decrease β-cell apoptosis
  • Slows gastric emptying
    • May decrease food intake (satiety)
who are the incretins
Who are the Incretins?
  • GI secreted –Incretins
    • Gastric inhibitory peptide (GIP) - aka glucose-dependent insulinotropic peptide
    • Glucagon-like peptide-1 and -2 (GLP-1, GLP-2)
      • GLP-1 is normally rapidly inactivated by enzyme dipeptidyl peptidase-IV (DPP-IV)
  • In DM type II
    • GIP levels are normal but peptide loses its ability to stimulate insulin secretion (function)
    • GLP-1 levels are decreased (quantity)
one more hormone amylin
One more hormone: amylin
  • Produced by the β-cell and is co-secreted with insulin.
  • Suppresses glucagon secretion
    • especially postprandial
  • Decreases postprandial hepatic GLC production
  • Decreases postprandial GLC levels
  • Reduces gastric emptying time
  • Centrally-mediated induction of satiety
  • In DM type II, amylin secretion is delayed and decreased (quantity)
glucose regulating hormones
Glucose-Regulating Hormones
  • In total, glucose control is dependent upon a complex interaction of multiple peptides:
    • Insulin (β-cells)
    • Glucagon (α-cells)
    • Incretins: GLP-1 and 2; GIP (L-cells)
    • Amylin (β-cells)
exenatide byetta glp 1 mimic
Exenatide (Byetta): GLP-1 mimic
  • Approved 6/2004
  • Synthetic version of exendin-4 (isolated from the toxic venom of the Gila monster)
  • Mechanism: Binds to GLP-1 receptor (mimic)
  • Resistant to DPP-IV and so has increased half-life
exenatide byetta
Exenatide (Byetta)
  • Injection (subcutaneous)
    • Pre-filled pen; 250 mcg/ml
  • Dose
    • 5 mcg BID within 60 minutes prior to a meal
    • After one month may increase to 10 mcg BID
  • Currently BID but may soon have a weekly formulation (Exenatide LAR)
exenatide byetta15
Exenatide (Byetta)
  • Most common side effect: Nausea
  • Benefits
    • Weight loss
    • Low risk of hypoglycemia
    • Animal studies—may help pancreas re-grow cells
  • Efficacy
    • When added to sulfonylureas or metformin additional lowering of HbA1c by 0.5-1%
  • Renal excretion
gliptins dpp iv inhibitor
Gliptins (DPP-IV inhibitor)
  • (Vildagliptin) Galvus & (Sitagliptin) Januvia
  • Inhibits the destruction of GLP-1 (DPP-IV inhibitor; dipeptidyl peptidase IV inhibitor)
  • Raise levels of the hormone GLP-1
    • Causes the pancreas to produce more insulin
  • Not as efficacious as metformin
  • Use as adjunct instead of sulfonylureas (avoid hypoglycemia and weight gain)
vildagliptin galvus
vildagliptin (Galvus)
  • Dose
    • 50 mg po daily or 50 mg po BID
  • Increased GLP-1 and GIP in DM type I and DM type II
  • Decrease triglycerides
  • Improved insulin sensitivity
  • Most common side effect:
    • Mild hypoglycemia
sitagliptin januvia
sitagliptin (Januvia)
  • Dose
    • 100 mg po daily or 200 mg po daily
  • Renal excretion
  • Is currently available on the market
flew under the radar
Flew Under the Radar
  • pramlintide (Symlin)
    • amylin mimic
    • FDA approved 3/2005
pramlintide symlin
pramlintide (Symlin)
  • Synthetic analog of human amylin
  • Mechanism: Supresses glucagon
  • Adjunctive therapy
    • Decrease insulin dose by 50% when add Symlin
  • Impact: approximately 1% reduction in A1c
  • Administration:
    • subcutaneous injection
    • cannot be mixed with insulin
pramlintide symlin21
pramlintide (Symlin)
  • Use and dosing: only for patients on insulin
    • Type I: 15 mcg immediately before meals, increase to target 30-60 mcg
    • Type II: 60 mcg immediately before meals, increase to target 120 mcg
  • Side effects
    • Hypoglycemia (*boxed warning)
    • Nausea
    • Headache
  • Benefits
    • Weight loss
inhaled insulin exubera
Inhaled Insulin (Exubera)
  • FDA approved 1/2006
  • Inhaled
  • Dose
    • 0.05 mg/kg (round down) TID within 10 minutes of a meal
    • 1 mg and 3 mg blisters
    • Three 1 mg blisters gives higher level than one 3 mg blister
    • Give two 1 mg blisters instead of one 3 mg blister if need to substitute
inhaled insulin exubera23
Inhaled Insulin (Exubera)
  • Side Effects
    • Respiratory sx, decreases in PFTs (baseline recommended)
    • Chest pain
    • Hypoglycemia
    • Xerostomia and Rash
    • Otitis media and ear pain (pediatrics)
  • If current smoker or quit within past 6 months then increased absorption may lead to increased risk of hypoglycemia
  • Renal excretion
key points
Key Points
  • New medications are adjuncts and do not replace insulin or glucophage (Metformin) as mainstays of treatment
  • Many of the medications are given with meals
  • exenatide (Byetta) may help with weight loss
  • sitagliptin (Januvia) is available; vildagliptin (Galvus) not yet on the market
  • Must decrease insulin dose 50% if add pramlintide (Symlin) because of hypoglycemia
  • These new therapies may alter the natural history of β-cell decline and hence delay progression of diabetes…these studies are in progress.
  • Berenson, A. 4 Diabetes Drugs are Seen Raising Hope and Profit. New York Times June 22, 2006.
  • Cefalu, W. T. Incretin-Based Therapeutics Strategies: A Clinical Perspective. Medscape.
  • Jeha G and Heptulla R. Newer therapeutic options for children with diabetes mellitus: theoretical and practical considerations. Pediatric Diabetes 2006: 7: 122-138.
  • Trujillo J. Incretin hormones in the treatment of type 2 diabetes. Formulary March 2006: 41: 130-141
  • Up to Date