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Latest updates to the XIGDUO XR Safety and Efficacy Clinical Trial page
- CheckyesterdayNo Change Detected
- Check2 days agoNo Change Detected
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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0 and now includes 8 locations, replacing the previous version v2.9.7.SummaryDifference0.5%
- Check5 days agoNo Change Detected
- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Type 2 diabetes FDA Drug and Device Resources Show less Design Details Observational Model : Case-Only Time Perspective: Prospective Primary Outcome Measures Outcome Measure Measure Description Time Frame Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI) Percentage (%) of AEs, SAEs and AESI in patients who are treated with Xigduo XR Nature, incidence and severity of AE in patients who are treated with Xigduo XR Nature, incidence and severity of unexpected adverse drug reactions in patients who are treated with Xigduo XR 12 or 24 weeks Secondary Outcome Measures Outcome Measure Measure Description Time Frame Hemoglobin A1c (HbA1c) Change in HbA1c in % during the observation period to evaluate effectivenss 12 or 24 weeks Fasting plasma glucose (FPG) Change in FPG in mg/dL during the observation period to evaluate effectivenss 12 or 24 weeks 2-hr post-prandial glucose (PPG-2hr) Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss 12 or 24 weeks Blood pressure Change in blood pressure in mmHg during the observation period to evaluate effectivenss 12 or 24 weeks Abdominal circumference Change in abdominal circumference in cm during the observation period to evaluate effectiveness 12 or 24 weeks Body weight Change in body weight in Kg during the observation period to evaluate effectiveness 12 or 24 weeks Overall investigator's assessment on the outcome of the treatment Overall investigator's assessment on the outcome of the treatment: 'Improved', 'Unchanged', 'Worsened', 'Assessment impossible' 12 or 24 weeks Number of Participants With Abnormal Laboratory Values Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study). Chemistry: AST, ALT, BUN, Cr, Na+, K+, Total cholesterol, TG Hematology: Hb, Hct Urinalylsis: Proteinurea 12 or 24 weeks Additional Relevant MeSH Terms Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Diabetes Mellitus, Type 2 Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by AstraZeneca D1691R00001 CSR synopsis Revision: v2.9.1'. This change represents an update in the study details and revision version to v2.9.1.SummaryDifference24%
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