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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 27, 2007 | ||||||||
| Last Updated Date | April 27, 2007 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
To investigate time to treatment in patients presenting with a hyperglycaemic emergency | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sub-Cutaneous Insulin in Hyperglycaemic Emergencies | ||||||||
| Official Title ICMJE | The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies | ||||||||
| Brief Summary | Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay. |
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| Detailed Description | This is a randomised trial concerning patients presenting in A & E with a diabetic emergency, either a Diabetic Ketoacidosis (DKA) or a Hyperosmolar Non-Ketotic Coma (HONC). Once informed consent has been given, each patient will receive standard intravenous treatment. They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo. Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Diabetes Mellitus | ||||||||
| Intervention ICMJE | Drug: Levemir | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00467246 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | HIPI2 | ||||||||
| Study Sponsor ICMJE | The Royal Bournemouth Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | The Royal Bournemouth Hospital | ||||||||
| Verification Date | April 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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