Type 2 diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: NovoRapid PenFlex
Product Name: NovoRapid PenFlex
Pharmaceutical Form: Injection*
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094236
Concentration unit: IU/ml international unit(s)/
Sponsors
Karolinska University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 according to clinical judgment. 3. Duration of type 2 diabetes = 12 months since diagnosis. 4. C-peptide ?0.4 nmol/L 5. Insulin naïve. Short term insulin treatment (7 days or less within the last 6 months) is allowed. 6. Oral anti-diabetic treatment for at least 4 months. 7. Age ? 35 and ?65 years, female or male. 8. BMI ? 35 kg/m2. 9. HbA1c =7.0% at screening and based on analysis from the central laboratory are eligible for the study. 10. Able and willing to adhere to the trial-specific insulin/OAD/exercise regimen for the entire trial period. 11. Able and willing to perform self-monitoring of blood glucose according to the protocol. 12. Able and willing to perform tests and examinations specified in the protocol. 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. Previous participation in this trial. Participation is defined as randomisation. 2. Receipt of any investigational drug within 4 weeks prior to this trial. 3. Anticipated change in dose of concomitant medication which may interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids. 4. Proliferative retinopathy or maculopathy that requires acute treatment or has had laser treatment within the last 6 months. 5. Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator. 6. Impaired hepatic function measured as alanine aminotransferase (ALAT) ? three times the upper reference limit based on analysis from the central laboratory. 7. Impaired renal function measured as S-creatinine ?130 µmil/L 8. Cardiac disease defined as : a. Unstable angina pectoris b. Myocardial infarction (MI) within the last 6 months c. Congestive heart failure NYHA class III and IV 9. Uncontrolled treated/untreated hypertension (systolic blood pressure ?180 mmHg and/or diastolic blood pressure ? 105mmHg). 10. Chronic foot ulcer. 11. Proliferative retinopathy. 12. Physical limitations which do not allow the patient to participate in an exercise training program. 13. Uncontrolled thyroid disorder. 14. Known or suspected allergy to trial product or related products. 15. Malignancy. 16. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. 17. Any other condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results. 18. GAD positive. 19. Tiazolidindione therapy within 6 months prior to trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate, in patients with type 2 diabetes treated with Metformin, the impact of adding long-term exercise training (20 weeks) or insulin treatment (insulin aspart) or the combination there of, on glycemic control. Glycemic control is determined as HbA1c after the total intervention period of 20 weeks. ;Secondary Objective: The secondary objectives are to compare the treatment regimens in terms of: - proportions of subjects with HbA1c -<6.0% or -< 5.5% after 20 weeks of treatment - proportions of subjects with HbA1c -< 6.0% or -< 5.5% without major hypoglycaemic events - proportions of subjects with HbA1c -< 6.0% or -< 5.5% without any hypoglycaemic events - incidence of hypoglycaemia, adverse events - change from baseline in HbA1c after 20 weeks of treatment - fasting plasma glucose levels, postprandial plasma glucose (PPG) levels and 8-point SMPG profiles - weight, waist, impedance and BMI change - insulin doses - CVD risk markers - serum markers of oxidative stress, 24-hours ambulatory blood pressure and endothelium-dependent vasodilatation - treatment satisfaction. - Quality of Life ;Primary end point(s): Primary endpoint: • HbA1c after 20 weeks of treatment | — |
Countries
Sweden
Outcome results
None listed