Elvira Fioriti

A multi-centre randomized trial of two different doses of nicotinamide in patients with recent-onset Type 1 diabetes (the IMDIAB VI)

Intensive insulin therapy is the gold standard by which Type 1 diabetes is treated. In addition to this therapy, administration of nicotinamide (NA) can be beneficial. This concept is reinforced by the results of a recent meta‐analysis of the use of NA in patients with recent‐onset Type 1 diabetes.

A 2-Year Pilot Trial of Continuous Subcutaneous Insulin Infusion Versus Intensive Insulin Therapy in Patients with Newly Diagnosed Type 1 Diabetes (IMDIAB 8)

In a pilot study, the metabolic effects of continuous subcutaneous insulin infusion (CSII) versus intensive subcutaneous insulin therapy (ISIT) started at diagnosis in patients with Type 1 diabetes and continued for a 2-year period were evaluated and compared. Twenty-three patients (between 12 and 35 years old, mean +/- SD 18.4 +/- 9 years) were randomized into two treatment groups (CSII vs. ISIT), and both received supplemental nicotinamide (NA), 25 mg/kg of body weight. CSII was started immediately after admission to the hospital. Parameters of metabolic control [insulin dose, hemoglobin A1c (HbA1c), and C-peptide] were evaluated for a 2-year follow-up period. Data are presented for a total of 19 patients who remained in the study for its duration. Two years after diagnosis, mean +/- SD HbA1c was 6.3 +/- 0.5% and 6.2 +/- 0.3% for the CSII and ISIT groups, respectively (p=not significant). Compared with baseline values, an increase of baseline C-peptide of 38% for the CSII group and 27% for the ISIT group was observed; however, the difference between the groups was not significant. The insulin requirement for the entire duration of the study, but not at entry and 3 months, was significantly higher in CSII compared with ISIT patients (0.62 +/- 0.4 IU/kg/day vs. 0.3 +/- 0.4 IU/kg/day, respectively; p<0.01). After trial completion patients on CSII continued with this mode of therapy. Implementation of CSII as well as ISIT at diagnosis of Type 1 diabetes and continuation for 2 years thereafter achieved similar and optimal metabolic control, but more insulin was required with the CSII group. Both types of intensive insulin therapy combined with NA are able to preserve C-peptide secretion or even increase baseline levels for up to 2 years after diagnosis.

A Novel Insulin Unit Calculator for the Management of Type 1 Diabetes

BACKGROUND Intensive insulin therapy is the gold standard therapy for type 1 diabetes (T1D) patients. To achieve optimal glycemic control, adjustments of insulin dose at mealtimes must be made taking into account several parameters: blood glucose levels, insulin/carbohydrate ratio, carbohydrate intake, and physical activity. Calsulin (Thorpe Products Ltd., Cambridge, UK) is a new tool for the administration of insulin dose before each meal. The aim of this study was to evaluate the efficacy of Calsulin on metabolic control in T1D patients undergoing intensive insulin therapy. SUBJECTS AND METHODS Forty consecutive patients affected by T1D, 18-65 years old, with disease duration of >1 year, were randomized to Calsulin or to the control group. Hemoglobin A1c (HbA1c) was evaluated at entry into the study and at 3- and 6-month follow-ups. Paired t test (two tailed) and analysis of variance were used to evaluate differences in HbA1c at 3 and 6 months in the two groups. RESULTS HbA1c at entry was 7.9 ± 1.0% (SD) in the Calsulin-treated group and 7.8 ± 1.6% (SD) in control patients (P not significant). Data showed a slight improvement in HbA1c levels at 3 months in the Calsulin-treated group (-0.61% vs. -0.14% difference, respectively; P not significant). At the 6-month follow-up, a significant reduction in HbA1c levels was observed in the Calsulin-treated group versus the control group (-0.85% vs. -0.07% difference, respectively; P < 0.05). CONCLUSIONS Calsulin is an acceptable and practical tool that makes the process of calculating insulin doses easy to use, and, most importantly, it improves metabolic control as shown by a significant reduction of HbA1c levels.

DiaPep277 peptide therapy in the context of other immune intervention trials in type 1 diabetes

Introduction: Type 1 diabetes (T1D) is characterized by the autoimmune destruction of pancreatic β-cells. The aim of immune intervention is to arrest this autoimmune attack. DiaPep277, a major T-cell epitope of heat shock protein 60 (hsp60), has been shown to be effective in the modulation of the immune response in recent onset T1D and is the main focus of this review in the context of other ongoing trials using different approaches. Areas covered: The authors performed a literature search of Pubmed listed publications (from the last 10 years) and a website search of the company licensing DiaPep277. DiaPep277 has been investigated in Phase I – III trials in humans. Phase II trials showed a significant preservation of β-cell function in adult T1D patients (but not children) with an absence of adverse effects and not accompanied by lower glycosylated haemoglobin (HbA1c) levels or reduced daily insulin requirement compared with placebo-treated patients. Expert opinion: Administration of DiaPep277 is safe and represents a promising therapeutic strategy in patients with recent-onset T1D. The results of two large Phase III trials will tell us whether this therapy may change our current approach to treating T1D patients at diagnosis.

Westernization of the Filipino population resident in Rome: obesity, diabetes and hypertension

Aims of the present study were to examine the anthropometrical and metabolic characteristics of the Filipino population migrant to the Southern European city of Rome, Italy.

Combination of nicotinamide and steroid versus nicotinamide in recent-onset IDDM. The IMDIAB II Study.

OBJECTIVE The aim of this study was to compare the effect of nicotinamide (NCT) alone or in combination with a cortisone-like substance, deflazacort (DFL), on the integrated parameters of metabolic control in patients with the recent-onset of insulin-dependent diabetes mellitus (IDDM). RESEARCH DESIGN AND METHODS Thirty-six patients who were diagnosed with diabetes between 5 and 35 years of age entered a randomized, double-blind, 1-year prospective study. Group A (n = 18) received NCT for 1 year (25 mg· kg–1 · day–1) plus DFL for 3 months (0.6 mg · kg–1 · day–1 in the first month, 0.3 mg · kg–1 · day–1 in the other 2 months). Group B (n = 18) received NCT for 1 year (25 mg · kg–1 · day–1) plus placebo forthe first 3 months. All patients were treated with intensified insulin therapy. RESULTS At 3 months after diagnosis, the insulin dose was significantly higher in group A compared with group B (P < 0.03) with similar HbA1 levels. Basal and stimulated C-peptide levels in group A of both adults and children were significantly higher compared with patients of group B (P < 0.05 and P <0.03, respectively). At the end of a 1-year follow-up, basal C-peptide did not differ between the two groups, although stimulated C-peptide was still significantly higher in patients of group A compared with group B (P < 0.05). Finally, insulin requirement did not differ between the two groups. CONCLUSIONS A short-term course of DFL therapy at diagnosis in addition to NCT slightly increases glucagon-stimulated but not basal β-cell function after 1 year.