Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the blood sugar and symptoms experienced during hypoglycaemia
Interventions
DRUGinsulin detemir
DRUGinsulin NPH
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise | From -40 min and until immediately before trial product administration |
Countries
United Kingdom
Outcome results
None listed