ADA: Pramlintide Decreases Glucose Fluctuations in Diabetics Using Pumps

Replacement of amylin with pramlintide reduces excessive glucose fluctuations in patients with type 1 diabetes.

In the setting of intensive insulin therapy, replacement of amylin with pramlintide reduces excessive glucose fluctuations in patients with type 1 diabetes, according to results reported here Friday at the 62nd Scientific Sessions of the American Diabetes Association (ADA).

Dr. Claresa Levetan with MedStar Clinical Research Center in San Diego, California, and colleagues used a continuous glucose monitoring system (CGMS) to evaluate the effect of pramlintide on glucose fluctuations in patients with type 1 diabetes intensively treated with insulin pumps (CSII).

They enrolled 24 patients with type 1 diabetes with a mean age of 42 years who were being treated with CSII. Twenty-two evaluable patients were randomized to receive preprandial injections for four weeks -- six of them with placebo and 18 with 30 µg pramlintide TID. Preprandial insulin doses were initially decreased by 10 percent to 20 percent. CGMS was used to measure interstitial glucose concentrations every five minutes over 24 hours at baseline and week 4, and two weeks after the end of the treatment period.

At enrollment, patients had excessive glucose fluctuations, spending on average 59 percent of the 24-hour period with a glucose value above 140 µg/dL, 13 percent below 80 µg/dL, and 28 percent in the euglycemic target range (80 to 140 µg/dL).

After four weeks on pramlintide, the time spent above the target range decreased to 48 percent, while time spent within the target range increased by 32 percent (to 37 percent). This shift from the hyperglycemic to the euglycemic range occurred without a relevant increase in the time spent below the target range (15 percent), without any severe hypoglycemic events, and with sustained preprandial insulin dose reductions of approximately 20 percent. At week six (off treatment), the 24-hour glucose profile reverted toward pre-treatment values.

Pramlintide was generally well tolerated, and nausea was the most common adverse event reported.

Dr. Levetan said the results show that the addition of pramlintide to insulin therapy in patients with type 1 diabetes intensively treated with SCII reduces excessive 24-hour glucose fluctuations by shifting glucose values from the hyperglycemic into the euglycemic target range, without increasing the time spent below the euglycemic range.

The addition of pramlintide to insulin therapy may therefore help patients more safely achieve their glycemic goals, he said.

Excessive 24-hour glucose fluctuations are a common abnormality in patients with type 1 diabetes, are comprised of hyperglycemic peaks and often unrecognized nocturnal hypoglycemia, and can hinder the attainment of glycemic targets. They have been demonstrated in both adult and adolescent patients with type 1 diabetes using continuous glucose monitoring technology and are present even in intensively treated patients who are in seemingly good overall glycemic control.

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