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Bergamo, Italy

Derosa G.,University of Pavia | Franzetti I.,Metabolic Unit | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 5 more authors.
Diabetes Research and Clinical Practice | Year: 2012

Aims: To evaluate the impact on glycemic control, insulin resistance, and insulin secretion of sitagliptin. +. metformin compared to metformin in type 2 diabetic patients. Methods: Patients were instructed to take metformin for 8 ± 2 months, then they were randomly assigned to sitaglipin 100. mg or placebo for 12 months. We evaluated at 3, 6, 9, and 12 months: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin/fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, adiponectin (ADN), and high sensitivity-C reactive protein (Hs-CRP). Before, and after 12 months since the addition of sitagliptin, patients underwent a combined euglycemic hyperinsulinemic and hyperglycemic clamp, with subsequent arginine stimulation. Results: Both treatments similarly decreased body weight, and BMI; on the other hand, they both improved glycemic control, glucagon and HOMA-IR, but sitagliptin. +. metformin were more effective in reducing these parameters. Sitagliptin. +. metformin, but not placebo. +. metformin, decreased FPPr, FPPR/FPI ratio, and increased C-peptide values, even if no differences between the groups were recorded. Sitaglitin. +. metformin gave also a greater increase of HOMA-β, M value, C-peptide response to arginine and disposition index compared to placebo. +. metformin group. Conclusions: Other than improving glycemic control, sitagliptin. +. metformin also improved β-cell function better than metformin alone. © 2012 Elsevier Ireland Ltd. Source


Derosa G.,University of Pavia | Cicero A.F.G.,University of Bologna | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Journal of the American Society of Hypertension | Year: 2013

The purpose of this study was to evaluate a fixed olmesartan/amlodipine combination on blood pressure control, lipid profile, insulin sensitivity, and some inflammatory markers compared with single-drug monotherapy. A total of 276 hypertensive patients were randomly assigned to olmesartan 20 mg, amlodipine 10 mg, or a single pill containing olmesartan/amlodipine combination 20/5 mg for 12 months. We evaluated the following at baseline and after 6 and 12 months: body weight, body mass index, systolic (SBP) and diastolic blood pressures (DBP), fasting plasma glucose (FPG), fasting plasma insulin (FPI), lipid profile, tumor necrosis factor-α (TNF-α), retinol binding protein-4 (RBP-4), and interleukins 6 and 7 (IL-6 and IL-7). At baseline, and after 6 and 12 months, patients underwent an euglycemic, hyperinsulinemic clamp. The olmesartan/amlodipine combination provided a greater decrease of SBP and DPB compared with amlodipine and olmesartan monotherapies. The olmesartan/amlodipine combination decreased FPG after 12 months compared with amlodipine monotherapy. The combination decreased FPI and homeostasis model assessment index and increased M value both compared with baseline and with olmesartan and amlodipine monotherapies. Olmesartan/amlodipine decreased IL-7, but not IL-6, compared with single drug components. The olmesartan/amlodipine combination is effective and safe in reducing blood pressure and has some additive effects not shown by single drugs, such as an improvement of IL-7. © 2013 American Society of Hypertension. All rights reserved. Source


Derosa G.,University of Pavia | D'angelo A.,University of Pavia | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Expert Opinion on Pharmacotherapy | Year: 2012

Aim: To evaluate the impact on glycemic control, insulin secretion and on insulin resistance of a sitagliptin + metformin combination compared to metformin monotherapy in type 2 diabetic, naïve to treatment, patients. Materials and methods: A total of 178 Caucasian type 2 diabetic patients were randomized to take sitagliptin 100 mg once a day or placebo in addition to previously taken metformin, for 12 months. The authors evaluated at 3, 6, 9, and 12 months: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin/fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, retinol binding protein-4 (RBP-4), visfatin, and chemerin. Before and 12 months after the addition of sitagliptin, patients underwent tests to assess insulin sensitivity and insulin secretion. Results: Sitagliptin + metformin gave a better decrease of glycemic control, HOMA-IR and glucagon levels compared to placebo + metformin; sitagliptin + metformin also better increased HOMA-β and all β-cell measurements recorded after the clamp. Regarding adipocytokines, sitagliptin + metformin better reduced RBP-4, visfatin and chemerin levels, compared to placebo + metformin. Conclusion: When metformin alone is not enough to reach an adequate glycemic control, sitagliptin can be a valid option, because of its effects in reducing insulin resistance and in preserving β-cell function. © Informa UK, Ltd. Source


Derosa G.,University of Pavia | D'Angelo A.,University of Pavia | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Internal Medicine | Year: 2013

Objective The effects of dipeptidyl peptidase-4 (DPP-4) inhibition on adipose tissue inflammation remain obscure. The aim of this study was to evaluate the effects of the addition of sitagliptin on the β-cell function and various inflammatory biomarkers in type 2 diabetic patients. Methods After a run-in period of taking metformin, 178 diabetic patients with poor glycemic control were randomized to take sitagliptin at a dose of 100 mg once a day or a placebo in addition to metformin for 12 months. We evaluated the following parameters at three, six, nine and twelve months: body mass index (BMI), glycemic control, the homeostasis model assessment insulin resistance index (HOMA-IR), the homeo-stasis model assessment β-cell function index (HOMA-β), the proinsulin/fasting plasma insulin ratio (Pr/FPI ratio) and the levels of fasting plasma insulin (FPI), fasting plasma proinsulin (FPPr), C-peptide, glucagon, resistin, vaspin, omentin-1 and tumor necrosis factor-α (TNF-α). Before and twelve months after the addition of sitagliptin, the patients underwent combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation to assess insulin sensitivity and secretion. Results Treatment with sitagliptin + metformin was more effective than placebo + metformin in improving glycemic control, the HOMA-IR and the glucagon level and increasing the HOMA-β and all β-cell measurements after combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation. Regarding inflammatory biomarkers, sitagliptin + metformin more effectively reduced the levels of resistin, vaspin and omentin-1 than placebo + metformin. Conclusion When treatment with metformin alone is not adequate for obtaining glycemic control, the addition of sitagliptin can be considered due to its actions in preserving the β-cell function and reducing the levels of biomarkers of inflammation. © The Japanese Society of Internal Medicine. Source


Derosa G.,University of Pavia | Franzetti I.,Metabolic Unit | Querci F.,Ospedale Pesenti Fenaroli | Romano D.,University of Pavia | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

Aim: To compare, using a continuous glucose monitoring (CGM) system, the effect on glycaemic variability of insulin glargine, detemir and lispro protamine. Methods: A total of 49 white people with type 1 diabetes, not well controlled by three times daily insulin lispro, taken for at least 2months before study and on a stable dose, were enrolled. The study participants were randomized to add insulin glargine, detemir or lispro protamine, once daily, in the evening. We used a CGM system, the iPro Digital Recorder (Medtronic MiniMed, Northridge, CA, USA) for 1week. Glycaemic control was assessed according to mean blood glucose values, the area under the glucose curve above 3.9mmol/l (AUC>3.9) or above 10.0mmol/l (AUC>10.0), and the percentage of time spent with glucose values >3.9 or >10.0mmol/l. Intraday glycaemic variability was assessed using standard deviation (s.d.) values, the mean amplitude of glycaemic excursions and continuous overlapping of net glycaemic action. Day-to-day glycaemic variability was assessed using the mean of daily differences. Results: The s.d. was found to be significantly lower with insulin lispro protamine and glargine compared with insulin detemir. AUC>3.9 was higher and AUC>10.0 was lower with insulin lispro protamine and glargine compared with detemir. The mean amplitude of glycaemic excursions and continuous overlapping net glycaemic action values were lower with insulin lispro protamine and glargine compared with detemir. In addition, the mean of daily differences was significantly lower with insulin lispro protamine and glargine compared with detemir. Fewer hypoglycaemic events were recorded during the night-time with insulin lispro protamine compared with glargine and detemir. Conclusions: The results suggest that insulin lispro protamine and glargine are more effective than detemir in reducing glycaemic variability and improving glycaemic control in people with type 1 diabetes. Insulin lispro protamine seems to lead to fewer hypoglycaemic events than other insulin regimens. © 2015 John Wiley & Sons Ltd. Source

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