Status:
UNKNOWN
Comparing Long-acting Insulins During Exercise in Type 1 Diabetes
Lead Sponsor:
Buckinghamshire Healthcare NHS Trust
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes are treated with...
Detailed Description
A1: At the first appointment, potential participants will be screened regarding the inclusion criteria, and if eligible to take part the study information sheet will be discussed with them in detail. ...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 Diabetes Mellitus (T1DM)
- HbA1c \< 10% or 86 mmol/mol
- Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin
- Exercising regularly for at least 1 hour per week on average
Exclusion
- People with any one of the following complications of diabetes:
- stage 2+ diabetic retinopathy
- renal impairment (with creatinine \>150micromol/l)
- known history or symptoms of cardiovascular disease
- foot ulceration
- peripheral vascular disease
- Pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
- Known or suspected allergy to or intolerance of any of the trial drugs or related products
- Receipt of any investigational drug within four months prior to Visit 0
- Known or suspected abuse of alcohol, narcotics or illicit drugs
- Any clinically significant disease or disorder which in the investigator's opinion could interfere with the results of the trial
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01440439
Start Date
November 1 2011
End Date
June 1 2012
Last Update
November 8 2011
Active Locations (1)
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1
Wycombe Hospital
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT