Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia
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Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise [ Time Frame: From -40 min and until immediately before trial product administration ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed and dated informed consent obtained before any trial-related activities.
Type 1 diabetes
Treatment with insulin for minimum three months
Duration of diabetes for more than 12 months
Body Mass Index (BMI) less than 30 kg/m2
HbA1c equal to or greater than 10 % based on analysis from central laboratory
Participation in any other clinical trial involving other investigational products within the last three months
Current treatment with insulin in a daily dose above 100 U
Episode of symptomatic hypoglycaemia, or a capillary plasma glucose value of less than 3.5 mmol/L in the past two weeks
Hypoglycaemic unawareness or severe autonomic neuropathy
Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
Current treatment with oral antidiabetic drugs
Impaired hepatic function measured as ALAT of more than two times the upper reference limit
Impaired renal function measured as creatinine of more than 150 micromol/L (1.7 mg/dL)
Cardiac problems defined as decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months
Known or suspected allergy to trial product or related products
Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
Blood donation of more than 500 mL within the last three months
Any condition that the Investigator and/or the Sponsor feels would interfere with study participation or evaluation of results
Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
Smeeton F, Shoajee-Moradie F, Jackson N, Westergaard L, Endahl L, Haahr HL, Umpleby M, Russell-Jones D. No Difference in Cognitive Function, Symptons or Counter-regulatory Responses after Induced Hypoglycemia in Subjects with Type 1 Diabetes. ADA 2007 2007; 56 (Suppl. 1): A168 (634-P)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):