title: Pharmacokinetics of an oral drug (acetaminophen) administered at various times relative to subcutaneous injection of pramlintide in subjects with type 2 diabetes.
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.
authors.affiliation: Amylin Pharmaceuticals, Inc, 9360 Towne Centre Drive, San Diego, CA 92121, USA.
authors.forename: Terrie A
authors.initials: TA
authors.lastname: Kellmeyer
authors.forename: Nicole C
authors.initials: NC
authors.lastname: Kesty
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.forename: Juan P
authors.initials: JP
authors.lastname: Frias
authors.forename: Mark S
authors.initials: MS
authors.lastname: Fineman
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000682:Amyloid / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology*; D004347:Drug Interactions; D005260:Female; D005746:Gastric Emptying; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D007279:Injections, Subcutaneous; D058228:Islet Amyloid Polypeptide; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method
chemical_list: D000682:Amyloid; D018712:Analgesics, Non-Narcotic; D007004:Hypoglycemic Agents; D058228:Islet Amyloid Polypeptide; D000082:Acetaminophen; C105254:pramlintide