TITLE

Pramlintide Improved Glycemic Control Without Increased Risk of Hypoglycemia in Patients With Type 2 Diabetes Using Basal Insulin

AUTHOR(S)
Lutz, Karen; Maier, Holly; Zhang, Bei; Frias, Juan
PUB. DATE
June 2007
SOURCE
Diabetes;Jun2007 Supplement 1, Vol. 56, pA143
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Pramlintide (PRAM), an analog of the beta-cell hormone amylin, improves glycemic control and reduces weight in patients with diabetes using mealtime insulin. PRAM has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. The current study investigated the efficacy and safety of PRAM in patients with type 2 diabetes (T2DM) using basal insulin (no mealtime insulin). This was a 16-wk, double-blind study in 211 patients with T2DM using insulin glargine ±OAs. Patients with no recurrent severe hypoglycemia during the previous 6 mo (age 55±9 y, A1C 8.5±0.9%, BMI 35±5 kg/m² ,DM duration 11 -± 6 y; mean ± SD) were randomized to PRAM or placebo (PBO) treatment with major meals. After optimization of PRAM dosage (60 or 120 µg), insulin was titrated targeting a FPG of <100 mg/dL. Baseline insulin doses were 48 ± 25 U PRAM and 54 ± 42 U PBO. Hypoglycemia was recorded during clinic and telephone visits. Severe hypoglycemia was defined as requiring medical intervention and/or the assistance of another individual. At Wk 16, A1C (-0.70 ± 0.11% vs. -0.36 ± 0.08%, P<0.05), mean PPG excursions (-24.4 ± 3.6 mg/dL vs. -0.4 ± 3.0 mg/dL, P<0.0001) and weight (-1.6 ± 0.3 kg vs. +0.7 ± 0.3 kg, P<0.0001) were significantly reduced in PRAM- vs. PBO-treated patients, respectively (mean ± SE). Wk 16 insulin doses (mean ± SD) were 61 ± 32 U PRAM (+35%) and 70 ± 50 U PBO (+37%), and FPG was 119.5±4.1 mg/dL PRAM and 122.8±4.3 mg/dL PBO (mean±SE). Mild-to-moderate hypoglycemia was experienced by 44% (0.81 events/patient·month) and 47% (0.86 events/patient·month) of PRAM- and PBO-treated patients, respectively, with no difference in daytime and nocturnal hypoglycemia between groups. Hypoglycemia occurred similarly in PRAM-and PBO-treated patients using SFU (57% vs. 55%). No treatment-related severe hypoglycemia occurred. PRAM + basal insulin titration improved glycemic control and reduced weight in patients with T2DM compared to PBO + basal insulin titration. Despite significantly improved glycemic control, the risk of hypoglycemia was not increased.
ACCESSION #
25820848

 

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