The effects of subcutaneous insulin detemir on glucose flux, pharmacokinetics and brain function in type one diabetes - The effects of insulin detemir in type 1 diabetes
- Conditions
- Type 1 diabetes mellitus
- Registration Number
- EUCTR2011-001642-14-GB
- Lead Sponsor
- niversity of Surrey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
1. Informed consent obtained before any trial-related activities. 2. Type 1 diabetes according to clinical judgement. 3. Duration of Type 1 diabetes greater than 12 months. 4. Current treatment basal bolus or biphasic insulin regimes. 5. Age greater than 18 years. 6. BMI of less than 35. 7. HbA1c of greater or equal to 5.5% and less than 9%. 8. Able and willing to complete the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Proliferative retinopathy that has required acute treatment within last three months. 2. Impaired hepatic or renal function as judged by the investigator. 3. Cardiac problems as judged by the investigator. 4. Uncontrolled hypertension. ( BP greater than 160/90) 5. Mental incapacity. 6. Pregnancy. 7. Known or suspected allergy to trial products. 8. Any other condition that the investigator feels would interfere with the trial participation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method