Type 1 Diabetes MedDRA version: 8.1 Level: LLT Classification code 10045228
Conditions
Interventions
Trade Name: Levemir
Product Name: Levemir
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Current Spons
Sponsors
Novo Nordisk Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject) 2. Type 1 diabetes 3. Duration of type 1 diabetes = 12 months 4. Current stable treatment: Basal-bolus insulin regimen = 3 months with at least once daily injection of intermediate-acting insulin, long-acting insulin or long-acting insulin analogues, and fast-acting insulin with each main meal 5. Age =18 years 6. HbA1c =9.0% based on analysis from the central laboratory 7. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Previous participation in this trial. Participation is defined as randomisation 2.Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids or mono amine oxidase (MAO) inhibitors 3.Use of any medication affecting heart rate (e.g. beta blockers) 4.Proliferative retinopathy or maculopathy that has required acute treatment within the last six months 5.Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by Investigator 6.Physical disability which may make exercise difficult 7.Impaired hepatic function measured as alanine aminotransferase (ALAT) =four times the upper reference limit based on analysis from the central laboratory 8.Impaired renal function measured as creatinine =150 µmol/l (1.7 mg/dl) based on analysis from the central laboratory 9.Cardiac disease defined as unstable angina pectoris, myocardial infarction (MI) within the last 6 months or congestive heart failure NYHA class II to IV 10.Uncontrolled treated/untreated hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure = 100 mmHg) 11.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation 12.Pregnancy, or the intention of becoming pregnant, breast feeding or judged not to be using adequate contraceptive measures. Adequate contraceptive methods are defined as sterilisation, IUD, oral contraceptives or consistent use of barrier methods 13.Known or suspected allergy to trial products or related products 14.Receipt of any investigational drug within one month prior to this trial 15.Current drug or alcohol abuse, known to the Investigator 16.Significant concomitant disease likely to interfere with the glucose metabolism, as judged by the Investigator 17.Any other condition that the Investigator feels would interfere with trial participation or evaluation of data 18. Abnormal, clinically significant findings on screening ECG. Exercise Test Day Exclusion Criteria (visits 4, 6, 8) 1.Subject informs the site that they are unable to attend the clinic on the scheduled day 2.Unusually strenuous exercise (as judged by the Investigator and / or subject) within 72 hours prior to each exercise test 3.Consumption of alcohol within 24 hours prior to an exercise test 4.Intake of caffeine after midnight on the night prior to an exercise test 5.Subject not fasting post breakfast on an exercise test day 6.Injection of bolus insulin after breakfast on an exercise test day 7.Injection of basal insulin after breakfast on an exercise test day 8.Clinically significant (as judged by the Investigator) hypoglycaemic episodes in the 24 hours prior to the subject arriving at the site for an exercise test 9.Visit 6 and 8: Fasting PG value outside of the range ± 3.0 mmol/l compared with the value at visit 4 10.Visits 6 and 8: Carbohydrate intake during the three days prior to the exercise test is significantly different from that at previous exercise tests (as determined by the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise; Secondary Objective: To compare the three basal insulin treatments in terms of; •Plasma glucose profiles pre and post exercise •Minimum plasma glucose value in the period 0-150 minutes post exercise (nadir) •Serum bolus insulin concentration immediately prior to and post exercise •Slope of Decline in plasma glucose post exercise •Self measured plasma glucose post exercise and at defined time points prior following each exercise test (4-point profile) •Counterregulatory hormone response •Incidence of hypoglycaemic episodes (major and minor) during and post exercise •Time between start of the exercise test and minimum plasma glucose value (first plasma glucose value <3.0mmol/l in case of hypoglycaemia) •The requirement and frequency of carbohydrate treatment during and post exercise •Incidence of adverse events •Standard clinical and laboratory safety parameters ;Main Objective: The objective of this study is to assess the impact of three basal insulin treatments on the maximum plasma glucose decline in people with Type 1 diabetes managed on a basal-bolus insulin regimen when performing physical exercise | — |
Countries
Germany, United Kingdom
Outcome results
None listed