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Total Daily Insulin Dose (total + daily_insulin_dose)
Selected AbstractsEfficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 2 2010T. Vilsbøll Objective: To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes. Methods: After a 2 week placebo run-in period, eligible patients inadequately controlled on long-acting, intermediate-acting or premixed insulin (HbA1c , 7.5% and , 11%), were randomised 1:1 to the addition of once-daily sitagliptin 100 mg or matching placebo over a 24-week study period. The study capped the proportion of randomised patients on insulin plus metformin at 75%. Further, the study capped the proportion of randomised patients on premixed insulin at 25%. The metformin dose and the insulin dose were to remain stable throughout the study. The primary endpoint was HbA1c change from baseline at week 24. Results: Mean baseline characteristics were similar between the sitagliptin (n = 322) and placebo (n = 319) groups, including HbA1c (8.7 vs. 8.6%), diabetes duration (13 vs. 12 years), body mass index (31.4 vs. 31.4 kg/m2), and total daily insulin dose (51 vs. 52 IU), respectively. At 24 weeks, the addition of sitagliptin significantly (p < 0.001) reduced HbA1c by 0.6% compared with placebo (0.0%). A greater proportion of patients achieved an HbA1c level < 7% while randomised to sitagliptin as compared with placebo (13 vs. 5% respectively; p < 0.001). Similar HbA1c reductions were observed in the patient strata defined by insulin type (long-acting and intermediate-acting insulins or premixed insulins) and by baseline metformin treatment. The addition of sitagliptin significantly (p < 0.001) reduced fasting plasma glucose by 15.0 mg/dl (0.8 mmol/l) and 2-h postmeal glucose by 36.1 mg/dl (2.0 mmol/l) relative to placebo. A higher incidence of adverse experiences was reported with sitagliptin (52%) compared with placebo (43%), due mainly to the increased incidence of hypoglycaemia (sitagliptin, 16% vs. placebo, 8%). The number of hypoglycaemic events meeting the protocol-specified criteria for severity was low with sitagliptin (n = 2) and placebo (n = 1). No significant change from baseline in body weight was observed in either group. Conclusion: In this 24-week study, the addition of sitagliptin to ongoing, stable-dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes. [source] Combination therapy using metformin or thiazolidinediones and insulin in the treatment of diabetes mellitusDIABETES OBESITY & METABOLISM, Issue 6 2005Suzanne M. Strowig The biguanide, metformin, sensitizes the liver to the effect of insulin, suppressing hepatic glucose output. Thiazolidinediones such as rosiglitazone and pioglitazone enhance insulin-mediated glucose disposal, leading to reduced plasma insulin concentrations. These classes of drugs may also have varying beneficial effects on features of insulin resistance such as lipid levels, blood pressure and body weight. Metformin in combination with insulin has been shown to significantly improve blood glucose levels while lowering total daily insulin dose and body weight. The thiazolidinediones in combination with insulin have also been effective in lowering blood glucose levels and total daily insulin dose. Triple combination therapy using insulin, metformin and a thiazolidinedione improves glycaemic control to a greater degree than dual therapy using insulin and metformin or insulin and a thiazolidinedione. There is insufficient evidence to recommend the use of metformin or thiazolidinediones in type 1 diabetic patients. Although these agents are largely well tolerated, some subjects experience significant gastrointestinal problems while using metformin. Metformin is associated with a low risk of lactic acidosis, but should not be used in patients with elevated serum creatinine or those being treated for congestive heart failure. The thiazolidinediones are associated with an increase in body weight, although this can be avoided with careful lifestyle management. Thiazolidinediones may also lead to oedema and are associated with a low incidence of hepatocellular injury. Thiazolidinediones are contraindicated in patients with underlying heart disease who are at risk of congestive heart failure and in patients who have abnormal hepatic function. The desired blood glucose-lowering effect and adverse event profiles of these agents should be considered when recommending these agents to diabetic patients. The potential for metformin or the thiazolidinediones to impact long-term cardiovascular outcomes remains under investigation. [source] Nocturnal hypoglycaemia in Type 1 diabetic patients, assessed with continuous glucose monitoring: frequency, duration and associationsDIABETIC MEDICINE, Issue 5 2007I. M. E. Wentholt Abstract Aims, We quantified the occurrence and duration of nocturnal hypoglycaemia in individuals with Type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple-injection therapy (MIT) using a continuous subcutaneous glucose sensor. Methods, A microdialysis sensor was worn at home by 24 patients on CSII (mean HbA1c 7.8 ± 0.9%) and 33 patients on MIT (HbA1c 8.7 ± 1.3%) for 48 h. Occurrence and duration of nocturnal hypoglycaemia were assessed and using multivariate regression analysis, the association between HbA1c, diabetes duration, treatment type (CSII vs. MIT), fasting and bedtime blood glucose values, total daily insulin dose and mean nocturnal glucose concentrations, and hypoglycaemia occurrence and duration was investigated. Results, Nocturnal hypoglycaemia , 3.9 mmol/l occurred in 33.3% of both the CSII- (8/24) and MIT-treated patients (11/33). Mean (± sd; median, interquartile range) duration of hypoglycaemia , 3.9 mmol/l was 78 (± 76; 57, 23,120) min per night for the CSII- and 98 (± 80; 81, 32,158) min per night for the MIT-treated group. Multivariate regression analysis showed that bedtime glucose value had the strongest association with the occurrence (P = 0.026) and duration (P = 0.032) of nocturnal hypoglycaemia. Conclusions, Microdialysis continuous glucose monitoring has enabled more precise quantification of nocturnal hypoglycaemia occurrence and duration in Type 1 diabetic patients. Occurrence and duration of nocturnal hypoglycaemia were mainly associated with bedtime glucose value. [source] The Effect of Metformin in Overweight Patients with Type 1 Diabetes and Poor Metabolic ControlBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2009Iben Brock Jacobsen Double-blinded intervention with 2000 mg metformin or placebo daily in 24 type 1 diabetic patients as adjunct to intensive insulin therapy. Primary endpoint was HbA1c, while secondary endpoints were body weight, frequency of hypoglycaemia, blood pressure, lipids, insulin dosage and self-monitored blood glucose profiles were measured. After 24 weeks, no difference in HbA1c was seen between the metformin and placebo groups (,0.5 ± 0.3 vs. ,0.2 ± 0.2%, P = 0.26. , mean ± S.E.M). Mean diurnal blood glucose profiles showed no statistical significant difference between the groups. The total daily insulin dose (IU) was significantly reduced in the metformin group compared to placebo after 24 weeks (,5.9 ± 2.2 vs. 2.9 ± 1.7, P = 0.004. , mean ± S.E.M). An increase in the frequency of hypoglycaemia was seen in the metformin group (0.7 ± 0.9 vs. 0.3 ± 0.5 events patient,1 week,1, P = 0.005), and a reduction in body weight was found using metformin compared to placebo (,3.0 ± 1.0 vs. 0.8 ± 1.1, P = 0.02. , mean ± S.E.M). Lipids and blood pressure did not differ significantly after intervention. Metformin, as adjunct to intensive insulin therapy, was associated with a reduction in the total daily insulin dose and a significant weight loss in patients with type 1 diabetes mellitus. [source] Insulin requirement in preschoolers treated with insulin pumps at the onset of type 1 diabetes mellitusACTA PAEDIATRICA, Issue 3 2009Agnieszka Szypowska Abstract The aim: The aim of this study is to analyze changes in the basal insulin requirement in preschoolers treated with insulin pump at the onset of T1DM, using system to calculate meal time insulin. Methods: 58 children (31 girls) under 6 years (mean age 3.3 ± 1.5 years) initiated on insulin pump therapy within 2 months after recognition of T1DM and treated at least for 1 year were analyzed during a follow-up period of 165 patient-years. Data was collected every 6 months: HbA1c, BMI SDS, diabetic ketoacidosis, severe hypoglycaemia, total daily insulin dose (TDD) and basal insulin. Results: Basal insulin rose from 10% in the third month and did not exceed 30% of TDD after 12 months (p<0.0001). In the third month, 46% of children were without basal insulin; this group included significantly older children (3.7 ± 1.4 vs. 2.8 ± 1.4 years; p = 0.01), which had lower TDD (0.33 ± 0.18 vs. 0.54 ± 0.23u/kg/d; p = 0.0007) than children with basal insulin. HbA1c persisted ,7.3%. Conclusion: In preschool children initiated on CSII therapy at the time of T1DM diagnosis the first year of treatment is critical for altering the basal insulin dose. Preschoolers with TDD lower than 0.5U/kg/d may not require basal insulin. Moreover, basal insulin did not exceed 30% of TDD in the first years after T1DM onset. [source] | ||||||||||