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Pramlintide reduces the risks associated with glucose variability in type 1 diabetes.

ABSTRACT: This study was designed to determine whether pramlintide added to insulin therapy reduced the risks associated with extreme blood glucose (BG) fluctuations in patients with type 1 diabetes.Self-monitored BG (SMBG) records were retrospectively analyzed from a randomized, double-blind, placebo-controlled study of the effects of pramlintide on intensively treated patients with type 1 diabetes. Two groups--pramlintide (n=119), 30/60 microg administered subcutaneously at each meal, or placebo (n=129)--were matched by age, gender, and baseline hemoglobin A1C. Using SMBG, daily BG profiles, BG rate of change, and low and high BG indices (LBGI and HBGI, respectively) measuring the risk for hypoglycemia and hyperglycemia were calculated.Compared with placebo, pramlintide significantly attenuated the pre- to postprandial BG rate of change (F=83.8, P<0.0001). Consequently, in pramlintide-treated patients, the average post-meal BG (8.4 vs. 9.7 mmol/L [151.2 vs. 174.6 mg/dL]) and postprandial HBGI were significantly lower than placebo (both P<0.0001). Substantial daily BG variation was observed in placebo-treated patients, with most significant hyperglycemia occurring after breakfast and during the night; post-meal BG did not vary significantly throughout the day in pramlintide-treated patients. The reduction in postprandial hyperglycemia in pramlintide-treated patients occurred without increased risk for preprandial hypoglycemia as quantified by the LBGI.Risk analysis of the effect of pramlintide treatment demonstrated risk-reduction effects independent of changes in average glycemia, most notably reduced rate and magnitude of postprandial BG fluctuations. These effects were not accompanied by an increased risk of hypoglycemia.

SUBMITTER: Kovatchev BP

PROVIDER: S-EPMC2979337 | biostudies-literature | 2008 Oct

REPOSITORIES: biostudies-literature

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Pramlintide reduces the risks associated with glucose variability in type 1 diabetes.

Kovatchev Boris P BP Crean John J McCall Anthony A

Diabetes technology & therapeutics 20081001 5

<h4>Background</h4>This study was designed to determine whether pramlintide added to insulin therapy reduced the risks associated with extreme blood glucose (BG) fluctuations in patients with type 1 diabetes.<h4>Methods</h4>Self-monitored BG (SMBG) records were retrospectively analyzed from a randomized, double-blind, placebo-controlled study of the effects of pramlintide on intensively treated patients with type 1 diabetes. Two groups--pramlintide (n=119), 30/60 microg administered subcutaneous ...[more]

PMID: 18715216

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Project description:BackgroundIt is presently unclear whether glycemic variability (GV) is associated with baroreflex sensitivity (BRS), which is an early indicator of cardiovascular autonomic neuropathy. The present study is the first to examine the relationships between BRS and GV measured using continuous glucose monitoring (CGM).MethodsThis was a multicenter, prospective, open-label clinical trial. A total of 102 patients with type 2 diabetes were consecutively recruited for this study. GV was assessed by measuring the standard deviation (SD), glucose coefficient of variation (CV), and the mean amplitude of glycemic excursions (MAGE) during CGM. The BRS was analyzed from electrocardiogram and blood pressure recordings using the sequence method on the first day of hospitalization.ResultsA total of 94 patients (mean diabetes duration 9.7?±?9.6 years, mean HbA1c 61.0?±?16.8 mmol/mol [7.7?±?1.5%]) were analyzed. In the univariate analysis, CGM-SD (r?=?-?0.375, p?=?0.000), CGM-CV (r?=?-?0.386, p?=?0.000), and MAGE (r?=?-?0.395, p?=?0.000) were inversely related to BRS. In addition to GV, the level of BRS correlated with the coefficient of variation in the R-R intervals (CVR-R) (r?=?0.520, p?=?0.000), heart rate (HR) (r?=?-?0.310, p?=?0.002), cardio-ankle vascular index (CAVI) (r?=?-?0.326, p?=?0.001), age (r?=?-?0.519, p?=?0.000), and estimated glomerular filtration rate (eGFR) (r?=?0.276, p?=?0.007). Multiple regression analysis showed that CGM-CV and MAGE were significantly related to a decrease in BRS. These findings remained after adjusting the BRS for age, sex, hypertension, dyslipidemia, HR, eGFR, CAVI, and CGM-mean glucose. Additionally, BRS was divided according to quartiles of the duration of diabetes (Q1-4). BRS decreased after a 2-year duration of diabetes independently of age and sex.ConclusionsGV was inversely related to BRS independently of blood glucose levels in type 2 diabetic patients. Measurement of BRS may have the potential to predict CV events in consideration of GV. Trial registration UMIN Clinical Trials Registry UMIN000025964, 28/02/2017.

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Pramlintide reduces the risks associated with glucose variability in type 1 diabetes.

Publications

Pramlintide reduces the risks associated with glucose variability in type 1 diabetes.

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