TITLE

Pramlintide Improved Glycemic Control and Reduced Weight Without Increased Hypoglycemia in Patients With Type 2 Diabetes Inadequately Controlled With Insulin Glargine ± Oral Agents

AUTHOR(S)
Riddle, Matthew; Brown, Carl; Bei Zhang; Maier, Holly; Lutz, Karen; Frias, Juan; Kolterman, Orville
PUB. DATE
June 2007
SOURCE
Diabetes;Jun2007 Supplement 1, Vol. 56, pA143
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
When type 2 diabetes (T2DM) is inadequately controlled with basal insulin ± oral agents (OAs), the usual options are increasing basal insulin or adding mealtime insulin. Limitations of these options include weight gain and increased risk of hypoglycemia. Pramlintide (PRAM), an analog of the beta-cell hormone amylin has been shown to reduce A1C, PPG, and body weight in patients with T2DM using basal + mealtime insulin. In the current study, we examined the efficacy and safety of PRAM as an alternative (rather than an addition) to mealtime insulin. In this 16-wk, randomized, double-blind study, 211 patients with T2DM using insulin glargine ±OAs were treated with PRAM or PBO with major meals. Patient demographics (age 55±9 y, DM duration 11±6 y, A1C 8.5±0.9%, BMI 35±5 kg/m²; mean±SD) were well-balanced between treatment groups. Baseline insulin doses were 48±25 U PRAM and 54±42 U PBO. After optimization of PRAM dosage (60 or 120 µg), insulin was titrated weekly, targeting an FPG of <100 mg/dL. Wk 16 insulin doses were 61±32 U PRAM and 70±50 U PBO. A1C (-0.70±0.11% vs. -0.36±0.08%, P<0.05) and mean PPG excursions (-24.4±3.6 mg/dL vs. -0.4±3.0 mg/dL, P<0.0001)(mean±SE) were reduced in PRAM-vs. PBO-treated patients. Improvements in glycemia were accompanied by progressive weight loss with PRAM and weight gain with PBO (-1.6±0.3 kg vs. +0.7±0.3 kg, P<0.0001). PRAM was generally well-tolerated, with the most frequent adverse events being mild-to-moderate hypoglycemia (PRAM 44%; PBO 47%) and nausea (PRAM 31%; PBO 10%). No treatment-related severe hypoglycemia occurred. More patients reached a composite outcome measure (A1C <7.0% or A1C reduction ≥0.5% AND no weight gain AND mean PPG excursions ≤40 mg/dL AND no severe hypoglycemia) with PRAM than with PBO (25% vs. 7%, P<0.001). In summary, PRAM + basal insulin titration improved A1C and PPG without weight gain or increased hypoglycemia compared to PBO + basal insulin titration in patients with T2DM.
ACCESSION #
25820850

 

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