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Week Clinical Trial (week + clinical_trial)

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Improvement of insulin sensitivity and ,-cell function by nateglinide and repaglinide in type 2 diabetic patients , a randomized controlled double-blind and double-dummy multicentre clinical trial

DIABETES OBESITY & METABOLISM, Issue 4 2007
J. Li
Aim:, To evaluate the efficacy of nateglinide vs. repaglinide in blood glucose (BG) control and the effect on insulin resistance and ,-Cell function in patients with type 2 diabetes. Methods:, A randomized controlled double-blind and double-dummy multicentre clinical trial was conducted. A total of 230 Chinese patients with type 2 diabetes were enrolled in five clinical centres. The patients were divided randomly into group A [repaglinide 1.0 mg three times daily (t.i.d.), n = 115] or group B (nateglinide 90 mg t.i.d., n = 115). At baseline and end of the 12-week clinical trial, standard mixed meal tolerance tests were performed. Results:, A total of 223 patients (96.9%) completed the trial. There was no significant difference between repaglinide and nateglinide groups in the effects of reducing fasting blood glucose (FBG), 30-, 60- and 120-min BG during 12 weeks (p > 0.05). At week 12, no significant difference was shown between the two groups in BG or haemoglobin A1c (HbA1c) (p > 0.05). However, the effect on HbA1c in repaglinide group was stronger than that in nateglinide group (p < 0.05). After 12-week treatment, area under the curve (AUC) of BG decreased (p < 0.05), and AUC of insulin and C-peptide (CP) increased in both groups (p < 0.05). The effects of nateglinide on AUC of BG, insulin and CP were similar to that of repaglinide (p > 0.05). There was no significant difference between the two groups in AUC of BG, insulin or CP in week 12 (p > 0.05). Furthermore, homeostasis model assessment of insulin resistance (HOMA-IR) and ,-cell function indexes measured by HOMA-,, ,I30/,G30 and (,I30/,G30)/HOMA-IR were improved significantly in both groups during 12 weeks (p < 0.05). The effects of improving HOMA-IR and ,-cell function indexes in nateglinide group were comparable with that of repaglinide group (p > 0.05). Conclusions:, The efficacy of repaglinide and nateglinide in FBG, postprandial glucose excursion and early-phase insulin secretion is similar. But the effect of repaglinide 1.0 mg t.i.d. on HbA1c is stronger than that of nateglinide 90 mg t.i.d.. This trial had shown that nateglinide and repaglinide could comparably improve insulin sensitivity and ,-cell function. [source]

HIV-related morbidity and mortality in patients starting protease inhibitors in very advanced HIV disease (CD4 count of <,50 cells/µL): an analysis of 338 clinical events from a randomized clinical trial,

HIV MEDICINE, Issue 2 2002
M Floridia
Background AIDS defining events occur infrequently in the presence of CD4 counts above 200 cells/µL. It is, however, uncertain for most of the AIDS defining conditions whether this threshold can be considered equally safe in patients with a previously very low CD4 nadir. Methods We evaluated in detail all the AIDS defining events observed during a 48-week clinical trial in 1251 nucleoside reverse transcriptase inhibitor-experienced patients who started protease inhibitors (PIs) at CD4 counts below 50 cells/µL. The type of event, immunological status at the moment of event and time between start of PI treatment and event occurrence were analysed cumulatively and by event type; event rates were calculated. Results Concomitant data on CD4 counts were available for 338 AIDS defining events (81% of total events). Median time between start of treatment with PI and event was 94.5 days and median absolute CD4 value at the occurrence of event was 20 per µL. Only 14 events (in 12 patients) were observed above the threshold of 200 CD4 cells/µL. An analysis of the 67 deaths with concomitantly available CD4 counts (57%) showed a median CD4 count of 10 cells/µL, with only four deaths occurring in the presence of a CD4 count above 100 cells/µL. Conclusions Very few clinical AIDS defining conditions were observed in patients who start PIs at very low CD4 counts and with treatment restore absolute values in CD4 counts above 200 cells/µL. This threshold can therefore be considered a clinically effective goal of treatment with respect to occurrence of all AIDS defining conditions in patients starting PIs in very advanced HIV disease. [source]

Efficacy of subgingivally applied minocycline in the treatment of chronic periodontitis

JOURNAL OF PERIODONTAL RESEARCH, Issue 1 2005
Hsein-Kun Lu
Background:, The use of adjunctive minocycline with mechanical debridement in treating periodontitis has been widely studied using different methods. However, the results from these studies are equivocal. Objective:, The purpose of this study was to clarify the efficacy of the adjunctive use of subgingival minocycline application plus scaling/root planing as compared with the results of one episode of scaling/root planing in the treatment of chronic periodontitis. Methods:, Fifteen patients were enrolled in this split-mouth clinical trial. Probing depth, clinical attachment loss, gingival index, and bleeding on probing were evaluated at the baseline before scaling/root planing and 6, 10, 14, and 18 weeks later according to a single-blind protocol. The amount of interleukin-1, (interleukin-1, pg/site) at each lesion was also simultaneously measured in gingival crevicular fluid in a parallel comparison design. After full-mouth baseline measurements and scaling/root planing, 78 lesions with a residual mean probing depth of 5 mm at anterior teeth were selected and equally distributed in either right or left sites based on a split-mouth symmetrical design and randomly assigned to one of two treatment groups (with or without minocycline administration, n = 39 for each group). Results:, Probing depth significantly decreased from the baseline (week 0) to week 6 after scaling/root planing (p < 0.05) in both groups, but there was no statistically significant difference between the two groups (p > 0.05). However, at weeks 10, 14, and 18, the experimental group showed significantly greater improvement in pocket reduction than the control group (p < 0.05). Similarly, both groups also showed significant decreases in gingival index scores from weeks 0,6 (p < 0.05), but gingival index reductions at weeks 10, 14, and 18 were statistically significant in favor of the experimental group (p < 0.05). The experimental group had more attachment gain than the control group at weeks 14 and 18 (p < 0.05). Values of interleukin-1, (pg/site) at the experimental sites were significantly reduced at weeks 10, 14, and 18, as compared to values at control sites (p < 0.01). Finally, the incidence of bleeding on probing showed no differences between the two groups for any time interval (p > 0.05). Conclusions:, In this 18-week clinical trial, the results suggested that scaling/root planing with adjunctive subgingival administration of minocycline ointment has a significantly better and prolonged effect compared to scaling/root planing alone on the reduction of probing depth, clinical attachment loss, gingival index, and interleukin-1, content, but not on bleeding on probing. [source]

Different response to rituximab in tumor necrosis factor blocker,naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: A twenty-four,week clinical trial,

ARTHRITIS & RHEUMATISM, Issue 5 2010
I.-H. Song
Objective Histologic studies have shown B cell clusters in the subchondral bone marrow of the spine of patients with ankylosing spondylitis (AS). An immunotherapy targeting B cells in AS is therefore of interest. We undertook this study to examine the efficacy and safety of rituximab in patients with AS refractory to nonsteroidal antiinflammatory drugs in whom previous treatment with tumor necrosis factor , (TNF,) blockers either had not been tried or had failed. Methods In this phase II clinical trial, 1,000 mg rituximab was administered intravenously at baseline and at week 2 in 20 patients with active AS. Ten of these patients had never received TNF blockers, and treatment with TNF blockers had failed in the other 10 patients. The primary end point was a 20% improvement in disease activity at week 24 according to the criteria of the Assessment of SpondyloArthritis international Society (an ASAS20 response). Results Seventy-five percent of the patients were male, 90% were HLA,B27 positive, their mean age was 39.7 years, and their mean disease duration was 16.8 years. Patients had active disease, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ,4. While there was no clear response at week 24 in the group in whom TNF blockers had failed (30% had achieved an ASAS20 response, 10% had achieved an ASAS40 response, none had achieved partial remission according to the ASAS criteria, and none had achieved 50% improvement on the BASDAI [a BASDAI50 response] beyond an expected placebo response), we observed a good improvement in the TNF blocker,naive group at week 24 (50% had achieved an ASAS20 response, 40% had achieved an ASAS40 response, 30% had achieved partial remission according to the ASAS criteria, and 50% had achieved a BASDAI50 response). Conclusion Although rituximab does not seem to be effective in patients with AS that does not respond to TNF blockers, it had significant efficacy in TNF blocker,naive patients. Therefore, further controlled trials with B cell,directed therapies should be performed in TNF blocker,naive AS patients in the future. [source]