Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a | Study results posted in trial register, publications specified in trial register | Endpoints quoted in publication(s)b,c | Endpoints quoted in abstract of publication(s)b,c | |
Umpierrez 2004a | N/T | Primary outcome measure(s): response to medical therapy: the time required for resolution of hyperglycaemia and ketoacidosis, and the rate of hypoglycaemia during insulin infusion | Primary outcome measure(s): ‐ | |
Secondary outcome measure(s): ‐ | Secondary outcome measure(s): ‐ | |||
Other outcome measure(s): levels of blood glucose, electrolytes, phosphorus, venous pH, beta‐hydroxybutyrate, free fatty acids, insulin; medical care data (site of admission and treatment in the hospital, amount of fluid and insulin administration, length of hospitalisation); deaths | Other outcome measure(s): duration of treatment until correction of hyperglycaemia and resolution of ketoacidosis, deaths, length of hospital stay, amount of insulin until resolution of diabetic ketoacidosis, rate of hypoglycaemia, hospitalisation charges | |||
Umpierrez 2004b | N/T | Primary outcome measure(s): time to resolve ketoacidosis | Primary outcome measure(s): ‐ | |
Secondary outcome measure(s): ‐ | Secondary outcome measure(s): ‐ | |||
Other outcome measure(s): levels of glucose, electrolytes, phosphorus, venous pH, beta‐hydroxybutyrate, free fatty acids, insulin; response to medical therapy (time and amount of insulin required for resolution of hyperglycaemia and ketoacidosis and the number of hypoglycaemic events during therapy) | Other outcome measure(s): duration of treatment until resolution of hyperglycaemia and ketoacidosis, total length of hospitalisation, amount of insulin administration until resolution of hyperglycaemia and ketoacidosis, number of hypoglycaemic events | |||
Della Manna 2005 | N/T | Primary outcome measure(s): ‐ | Primary outcome measure(s): ‐ | |
Secondary outcome measure(s): ‐ | Secondary outcome measure(s): ‐ | |||
Other outcome measure(s): blood glucose, blood gas, beta‐hydroxybutyrate, electrolytes, phosphate, magnesium, urea nitrogen, creatinine, urine ketones; resolution of metabolic acidosis and ketosis, DKA recovery; (near) deaths, cerebral oedema; hypoglycaemic episodes | Other outcome measure(s): blood glucose, blood gas, beta‐hydroxybutyrate, electrolytes, metabolic acidosis and ketosis, DKA recovery | |||
Ersöz 2006 | N/T | Primary outcome measure(s): ‐ | Primary outcome measure(s): ‐ | |
Secondary outcome measure(s): ‐ | Secondary outcome measure(s): ‐ | |||
Other outcome measure(s): serum glucose, pH, beta‐hydroxybutyrate, electrolytes, urine ketone levels and urinary output, lipids; resolution of ketoacidosis, time elapsed until normalisation of the monitored parameters, total amount of insulin delivered until resolution of DKA; mortality, hypoglycaemic events | Other outcome measure(s): time needed for normalisation of serum glucose, beta‐hydroxybutyrate, blood pH and urine ketone levels; mortality, serious side effects | |||
Karoli 2011 | N/T | Primary outcome measure(s): ‐ | Primary outcome measure(s): ‐ | |
Secondary outcome measure(s): ‐ | Secondary outcome measure(s): ‐ | |||
Other outcome measure(s): blood glucose levels, resolution of DKA, response to therapy was assessed by time and amount of insulin required for resolution of hyperglycaemia and ketoacidosis, number of hypoglycaemic events; duration of hospital stay; deaths | Other outcome measure(s): response to therapy (duration of treatment and amount of insulin administered until resolution of hyperglycaemia and ketoacidosis, total length of hospital stay, and number of hypoglycaemic events); mortality | |||
‐ denotes not reported aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturers' websites, trial registers) bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents, or multiple reports of a primary study) cOther outcome measures refer to all outcomes not specified as primary or secondary outcome measures DKA: diabetic ketoacidosis; EMA: European Medicines Agency; FDA: US Food and Drug Administration; N/T: no trial document available |