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To compare the glycaemic control of an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily in combination with metformin to that of once-daily insulin glargine plus metformin in patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy.Ninety-seven patients were randomized in a multicentre, open-label, 32-week crossover study. Primary variables evaluated: haemoglobin A1c (A1c), 2-h post-prandial blood glucose (BG), hypoglycaemia rate (episodes/patient/30 days), incidence (% patients experiencing≥ 1 episode) of overall and nocturnal hypoglycaemia.At endpoint, A1c was lower with the insulin lispro mixture plus metformin compared with glargine plus metformin (7.54% ± 0.87% vs. 8.14% ± 1.03%,P < 0.001). Change in A1c from baseline to endpoint was greater with the insulin lispro mixture plus metformin (−1.00% vs.−0.42%;P < 0.001). Two-hour post-prandial BG was lower after morning, midday, and evening meals (P < 0.001) during treatment with the insulin lispro mixture plus metformin. The fasting BG values were lower with glargine plus metformin (P = 0.007). Despite lower BG at 03.00 hours (P < 0.01), patients treated with the insulin lispro mixture plus metformin had a lower rate of nocturnal hypoglycaemia (0.14 ± 0.49 vs. 0.34 ± 0.85 episodes/patient/30 days;P = 0.002), although the overall hypoglycaemia rate was not different between treatments (0.61 ± 1.41 vs. 0.44 ± 1.07 episodes/patient/30 days;P = 0.477).In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice-daily insulin lispro mixture plus metformin, which targets both post-prandial and pre-meal BG, provided clinically significant improvements in A1c, significantly reduced post-prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once-daily glargine plus metformin, a treatment that targets fasting BG.Diabet. Med. (2005) [ABSTRACT FROM AUTHOR]

Aim: To compare pre-meal injection of Humalog Mix50 (Mix50) and Humalog Mix25 (Humalog Mix75/25 in the US; Mix25) with respect to 2 h postprandial (2 h pp) blood glucose (BG) control after a carbohydrate-rich breakfast in patients with type 2 diabetes., Research Design and Methods: One hundred and sixteen patients were enrolled in a 16-week crossover trial and received two treatment regimens in a randomized crossover fashion: (i) Mix50 before breakfast and Mix25 before the evening meal (Mix50/Mix25) and (ii) Mix25 before both breakfast and the evening meal (Mix25 twice daily). Insulin doses were adjusted according to stated glycaemic targets. After 6 and 8 weeks of treatment, the patient's usual morning insulin dose was administered, followed immediately by a test breakfast representative of the patient's usual breakfast meal. Fasting and 2 h pp BG concentrations were measured at the time of the test meal. Haemoglobin A1c (A1C) was measured, and information regarding hypoglycaemia (symptoms) was collected at the end of each treatment period., Results: Insulin doses were similar between treatments (morning = 31-33 U, evening = 26-28 U) at endpoint. Following the test breakfast, the 2 h pp BG was lower (10.9 +/- 0.3 mmol/l vs. 12.4 +/- 0.3 mmol/l, p = 0.0012) and the 2 h pp BG excursion was smaller (1.4 +/- 0.28 mmol/l vs. 3.5 +/- 0.28 mmol/l, p < 0.001) during treatment with Mix50/Mix25 than during treatment with Mix25 twice daily. There was no difference between the treatments with respect to fasting BG (Mix50/Mix25, 9.5 +/- 0.3 mmol/l vs. Mix25 twice daily, 8.9 +/- 0.3 mmol/l; p = NS), A1C (8.14% +/- 1.14% vs. 8.14% +/- 1.07%; p = NS) or the incidence of self-reported hypoglycaemia (34% vs. 23%; p = NS)., Conclusions: Compared with treatment with Mix25 twice daily, treatment with Mix50 before breakfast and Mix25 before the evening meal resulted in better pp glycaemic control following a carbohydrate-rich meal, and similar fasting BG, A1C and incidence of hypoglycaemia in patients with type 2 diabetes.

Objective: To determine the extent of low total-body bone mineral content (BMC) in non-corticosteroid-treated white postpubertal females with juvenile rheumatoid arthritis (JRA) compared with healthy age- and race-matched female controls, and to identify variables that significantly contribute to total-body BMC., Methods: Thirty-six females with definite JRA who had never received corticosteroids and 51 healthy female controls were evaluated. All subjects had had their first menstrual period at least 2 years prior to enrollment. Total-body BMC, lumbar spine bone mineral density, and body composition were determined by dual x-ray absorptiometry. Total-body BMC Z-scores were calculated for JRA patients using data from controls. JRA patients were dichotomized into those with "normal" bone mass (total-body BMC at or above the mean or no more than 1 SD below the mean) and those with "low" bone mass (total-body BMC more than 1 SD below the mean). Comparisons of anthropometric measurements, laboratory measurements of bone metabolism, disease activity, dietary intake, and physical activity were performed. Stepwise logistic regression was utilized to determine the presence or absence of low total-body BMC and to identify associated contributing factors., Results: Total-body BMC was 4.5% lower in JRA patients than in controls (mean +/- SD 2,050 +/- 379 gm versus 2,143 +/- 308 gm; P = 0.21). Twenty-five of 36 patients (69.4%) had "normal" and 11 of 36 (30.6%) had "low" total-body BMC. Comparison of JRA patients with "normal" versus those with "low" total-body BMC revealed significant differences in disease characteristics, anthropometric and physical development characteristics, laboratory measures of bone mineralization, and dietary intake. The final regression model contained only lean mass (P = 0.01), which accounted for 76.3% of the variance in total-body BMC. The odds ratio for lean mass was 0.4451 (95% confidence interval 0.2374-0.8348)., Conclusion: In this study, approximately 30% of the subjects in a sample of postpubertal female patients with mild-to-moderate, non-corticosteroid-treated JRA had low bone mass. The predictor variable that significantly contributed to total-body BMC was lean mass, which demonstrated a protective effect of 0.56 risk reduction for low total-body BMC.

Objective: To determine the extent of significant osteopenia in prepubertal patients with juvenile rheumatoid arthritis (JRA) not treated with corticosteroids and to identify variables that are highly related to bone mineralization in this population., Methods: In a cross-sectional study, 48 JRA patients and 25 healthy control subjects ages 4.6-11.0 years were evaluated. Total body bone mineral density (TB BMD) was determined by Hologic dual energy x-ray absorptiometry. All patients were prepubertal (Tanner stage I or II) and had never taken corticosteroids. For comparison, JRA patients were divided into "low" TB BMD (Z score < or =-1) or "normal" TB BMD (Z score >-1)., Results: The overall mean +/- SD TB BMD scores did not differ between the JRA subjects (0.75 +/- 0.06 gm/cm2) and controls (0.73 +/- 0.07 gm/cm2; P > 0.30). However, 29.2% of the JRA patients had low TB BMD, whereas only 16% would be expected to have low TB BMD based on the standard normal distribution (goodness of fit chi(2) = 4.84, P = 0.01). The mean Z score for the JRA patients with low TB BMD was -1.43, and for those with normal TB BMD, it was 0.32. The JRA subjects with low TB BMD were significantly younger, had more active articular disease, greater physical function limitation, higher erythrocyte sedimentation rate, higher joint count severity score, lower body mass index, lower lean body mass, less participation in organized sports, and more protein and vitamin D in their diet compared with JRA patients with normal TB BMD (all P < 0.05). Using logistic regression, a model including age at JRA onset, Juvenile Arthritis Functional Assessment Report (JAFAR) score, triceps skin-fold percentiles, percentage US recommended daily allowance for dietary magnesium intake, and serum 1,25-dihydroxyvitamin D levels was able to accurately segregate 79.6% of the JRA subjects into either the low or normal TB BMD groups (chi(2) = 20.5, P = 0.001)., Conclusion: This study demonstrated that in a mildly to moderately ill prepubertal JRA population that had never been exposed to corticosteroids, almost 30% had significantly low TB BMD. The patients with low TB BMD had more active and severe articular disease and greater physical function limitation. Disease-related parameters in JRA appear to exert a negative effect on bone mineralization even in prepubertal children, which can be demonstrated despite the exclusion of corticosteroid-treated patients.