Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00760448
- Lead Sponsor
- Novo Nordisk A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Guildford, United Kingdom