Pharmacokinetics of an oral drug (acetaminophen) administered at various times relative to subcutaneous injection of pramlintide in subjects with type 2 diabetes

J Clin Pharmacol. 2007 Jul;47(7):798-805. doi: 10.1177/0091270007300949. Epub 2007 Apr 26.

Abstract

Pramlintide, an adjunct treatment to mealtime insulin for patients with type 2 and type 1 diabetes, aids glycemic control by suppressing postprandial glucagon secretion, slowing gastric emptying, and enhancing satiety. Because gastric emptying affects oral medication absorption, this placebo-controlled, single-blind, crossover study examined the absorption of 1000 mg of acetaminophen elixir administered -2, -1, 0, +1, and +2 hours relative to pramlintide (120 microg) or 0 hours relative to placebo in 24 patients with type 2 diabetes. When acetaminophen administration occurred 0, +1, or +2 hours relative to pramlintide, the maximum observed plasma concentration of acetaminophen decreased 14% to 29%, and time to maximum observed plasma concentration increased by 0.8 to 1.2 hours compared with administration 0 hours relative to placebo. Pramlintide treatment slowed but did not alter the extent of acetaminophen absorption (area under the concentration-time curve). No serious adverse events or withdrawals were reported. Oral agents should be administered at least 1 hour before or 2 hours after pramlintide injection if rapid onset of action is required for efficacy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetaminophen / administration & dosage
  • Acetaminophen / blood
  • Acetaminophen / pharmacokinetics*
  • Administration, Oral
  • Adolescent
  • Adult
  • Amyloid / administration & dosage
  • Amyloid / blood
  • Amyloid / pharmacology*
  • Analgesics, Non-Narcotic / administration & dosage
  • Analgesics, Non-Narcotic / blood
  • Analgesics, Non-Narcotic / pharmacokinetics*
  • Area Under Curve
  • Cross-Over Studies
  • Diabetes Mellitus, Type 2 / physiopathology*
  • Drug Interactions
  • Female
  • Gastric Emptying
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / blood
  • Hypoglycemic Agents / pharmacology*
  • Injections, Subcutaneous
  • Islet Amyloid Polypeptide
  • Male
  • Middle Aged
  • Single-Blind Method

Substances

  • Amyloid
  • Analgesics, Non-Narcotic
  • Hypoglycemic Agents
  • Islet Amyloid Polypeptide
  • Acetaminophen
  • pramlintide