Type 1 Diabetes MedDRA version: 14.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Levemir FlexPen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
Buckinghamshire Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Male or Female, aged between 18 and 65 years 3. Diagnosed with Type 1 Diabetes Mellitus (T1DM) 4. Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin 5. Exercising regularly for at least 1 hour per week on average 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
Exclusion criteria
Exclusion criteria: 1. People with any one of the following complications of diabetes: a. stage 2+ diabetic retinopathy b. renal impairment (with creatinine >150micromol/l) c. known history or symptoms of cardiovascular disease d. foot ulceration e. peripheral vascular disease 2. Pregnancy or breastfeeding 3. Untreated or unstable respiratory disease 4. Known hypoglycaemia unawareness 5. Treatment with drugs known to interfere with glucose metabolism 6. Known or suspected allergy to or intolerance of any of the trial drugs or related products 7. Receipt of any investigational drug within four months prior to first appointment 8. Known or suspected abuse of alcohol, narcotics or illicit drugs 9. Any clinically significant disease or disorder which in the investigator’s opinion could interfere with the results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify whether or not there is a difference in effect on blood glucose levels during and after a period of exercise of moderate intensity between the two background insulins most commonly used in type 1 diabetes, the insulin analogues insulin glargine and insulin detemir.;Secondary Objective: To identify whether or not there is a difference in the effect on metabolism during and after a period of exercise of moderate intensity between the two background insulins most commonly used in type 1 diabetes, the insulin analogues insulin glargine and insulin detemir. ;Primary end point(s): The primary outcome measure is glucose excursion (that is the change in blood glucose levels) between the start and the finish of one hour of exercise. | — |
Countries
United Kingdom
Outcome results
None listed