Type II diabetes mellitus MedDRA version: 8.0 Level: LLT Classification code 10045242
Conditions
Sponsors
Novo Nordisk Pharma GmbH
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 procedure that would not have been performed during normal management of the subject) 2. Type 2 diabetes 3. Duration of type 2 diabetes = 6 months 4. Current treatment with 1 or more oral antidiabetic drugs (OADs), premixed insulin, intermediate-acting insulin, long-acting insulin or combination of these for more than 3 months 5. Age = 18 years, female and male 6. BMI = 40 kg/m2 7. HbA1c = 7.0 % and = 11.0 % at screening based on analysis from central laboratory 8. Able and willing to perform daily self-monitoring of blood glucose with multiple measurements per day 9. Able and willing to use multiple daily injections regimen for the entire trial 10. Likely to comply with the Investigator’s instructions 11. Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator. Acceptable contraceptive methods are barrier methods, contraceptive pills or intrauterine device (IUD). 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to a trial product or related products. 2. Previous participation in this trial. 3. Previous treatment with short acting insulin(s) for longer than 10 days 4. Current treatment with thiazolidinediones (TZDs). A TZD medication must be stopped at least 14 days before the randomisation that is a subject could be randomised if TZDs are stopped at Visit 1 and the time between V1 and V2 is at least 2 weeks). 5. Anticipated change in dose of concomitant medication known to interfere clinically relevant with glucose metabolism, such as e.g. systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids. 6. Current drug or alcohol abuse, known to the Investigator. 7. Known hypoglycaemia unawareness, recurrent major hypoglycaemia or frequent hypoglycaemic events, as judged by the Investigator. 8. Significant concomitant disease likely to interfere with the glucose metabolism at the discretion of the Investigator. 9. Proliferative retinopathy or maculopathy that requires acute treatment or subject has had laser treatment within the last 6 months. If the screening fundoscopy does not clearly indicate, if a retinopathy is proliferative or non-proliferative, or if a treatment is recommended, or if it is not clear, when a previous laser treatment had been performed, the subject must not be randomised for safety reasons. 10. Impaired hepatic function measured as alanine aminotransferase (ALAT) = four times the upper reference limit based on analysis from the central laboratory. 11. Impaired renal function measured as creatinine = 150 µmol/l (1.7 mg/dl) based on analysis from the central laboratory. 12. Cardiac disease defined as unstable angina pectoris, myocardial infarction (MI) within the last 6 months or congestive heart failure NYHA class III and IV 13. Uncontrolled treated/untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 105 mmHg) 14. Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results. 15. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. 16. Pregnancy, breast-feeding or the intention of becoming pregnant. 17. Receipt of any investigational drug within 4 weeks prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the glycaemic control, measured as HbA1c after 52 weeks of treatment, in patients with type 2 diabetes treated with a supplementary insulin therapy (SIT+) being randomized either to a SIT+ fixed dose regimen or to a SIT+ flexible dose regimen including more intensive education and therapy control.;Secondary Objective: The secondary objectives are to compare the two regimens in terms of: ? 9-point self-measured glucose profiles after 12, 26, 39 and 52 weeks ? HbA1c after 12, 26 and 39 weeks ? Percentage of subjects with HbA1c < 7 % after 52 weeks ? duration of education ? changes of quality of life to baseline after 26 and 52 weeks ? insulin doses per day ? frequency of blood glucose measurements ? weight development ? incidence of hypoglycaemic episodes ? incidence of adverse events ? standard safety;Primary end point(s): Efficacy endpoints ? HbA1c after 12, 26, 39 and 52 weeks ? Percentage of subjects with HbA1c < 7 % after 52 weeks ? 9-point self-measured glucose profiles after 12, 26, 39 and 52 weeks Safety endpoints ? Incidence of adverse events ? Weight development ? Incidence of hypoglycaemic episodes (all, nocturnal, major, minor, symptoms only) ? Haematology, biochemistry ? Fundoscopy ? Vital signs Other endpoints ? Duration of education ? Insulin dose per day ? Frequency of blood glucose measurements ? Changes in Quality of life after 26 and 52 weeks | — |
Countries
Germany
Outcome results
None listed