OBJECTIVE -To assess the effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes treated with intensive insulin regimens. [MDI] or continuous subcutaneous insulin infusion [CSII] pump therapy) patients with type 1 diabetes completed a study-specific treatment satisfaction questionnaire following 29 weeks of either placebo (n ϭ 136) or pramlintide (n ϭ 130) treatment in a double-blind, noninferiority pramlintide dose titration trial. End points included patient reported outcomes, their relationship to insulin treatment regimen, A1C, weight, and insulin use.
RESEARCH DESIGN AND METHODS -Intensively treated (multiple daily injectionRESULTS -Pramlintide-treated patients reported greater treatment satisfaction in most questionnaire responses. Treatment satisfaction was similar for pramlintide-treated patients regardless of intensive insulin regimens (MDI versus CSII). Mean A1C was reduced to a similar degree in both pramlintide-(Ϫ0.39 Ϯ 0.07%) and placebo-treated (Ϫ0.45 Ϯ 0.07%) patients. However, pramlintide treatment was associated with reductions in mean body weight (Ϫ1.50 Ϯ 0.33 kg; P Ͻ 0.0001) and mealtime insulin use (Ϫ19.05 Ϯ 5.17%; P Ͻ 0.005) over 29 weeks, while placebo treatment resulted in weight gain (1.28 Ϯ 0.25 kg) and a smaller reduction in mealtime insulin use (Ϫ2.20 Ϯ 3.33%).CONCLUSIONS -Despite similar reductions in A1C, pramlintide treatment resulted in greater treatment satisfaction compared with placebo treatment. This was independent of insulin delivery method.
Diabetes Care 30:210 -216, 2007
In this uncontrolled, open-label setting, pramlintide initiation while reducing mealtime insulin, followed by insulin dose optimization, resulted in improvements in postprandial glucose excursions and A1C. These improvements in glycemic control were accompanied by weight loss.
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.
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