type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Aspart
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject) 2.Type 2 diabetes mellitus = 6 months (at visit 2) 3.Age = 18 years (at visit 1) 4.HbA1c = 7.5% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergy to trial product(s) or related products 2.Previous participation in any trial for the last 3 months 3.Previous participation in this trial defined as past inclusion at visit 2 4.Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 50 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). UK: Adequate contraceptive measures are defined as sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods 5.Use of more than 1 U/kg of basal insulin daily (at Visit 1) 6.Treatment with a-glucosidase inhibitors (at Visit 1) 7.Treatment with GLP-1 mimetics or DPP-IV inhibitors (at Visit 1) 8.Active proliferative retinopathy or maculopathy requiring treatment within 6 mnths prior to screening 9.Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening 10.Uncontrolled hypertension (treated or untreated) as judged by the Investigator 11.Any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial 12.Recurrent (> 2 episodes) hypoglycaemia with PG < 3.1 mmol/L (55.8 mg/dL) within the last month or hypoglycaemic unawareness as judged by the investigator 13.Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non-selective beta-blockers 14.Substance abuse including abuse of anabolic steroids 15.Mental incapacity or language barrier precluding adequate understanding and/or cooperation 16.Any condition that the investigator and/or Sponsor consider a potential obstacle to trial participation and/or data analysis 17.Treatment with other insulin than those described in inclusion criteria no. 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if IAsp added step-wise (1-2-3) in a Basic regimen (according to the largest meal, and titrated based mainly on pre-meal SMPG) is equivalent to IAsp added step-wise (1-2-3) in an Advanced regimen (according to the largest prandial increment, and titrated based mainly on post-meal SMPG) as measured by HbA1c after 36 weeks of treatment in subjects with type 2 diabetes treated with once daily IDet in combination with OAD(s).;Secondary Objective: To compare the proportion of subjects achieving HbA1c levels <7.0% at 11, 23 and 36 weeks with IAsp at the largest meal (Basic Basal Plus regimen) vs. IAsp at the meal with the largest prandial increment (Advanced Basal Plus regimen), both as add-on to IDet and OADs?To compare the FPG at 36 weeks?Compare the average prandial increments?Compare the % of subjects with post prandial PG readings above 8.0 mmol/L or 11.1 mmol/L ?Compare the safety profile as measured by occurrence of AEs?Compare the safety profile as measured by changes in lab. safety parameters, physical examination, and vital signs?Compare the relative incidence of hypoglycaemia?Other objectives?Compare changes in body weight, BMI, waist/hip circumference?Evaluate the distribution of bolus injections by meal and number of boluses?Evaluate insulin doses?Evaluate the average daily bolus insulin doses?Assess the distribution of subjects on 1, 2 or 3 boluses of IAsp?Assess and compare Patient Reported Outcomes.;Primary end point(s): Key Efficacy Endpoints •HbA1c (cf. Section 8.2.1) •1-, 4-, 6- and 7-point SMPG profiles (cf. Section 8.2.4) •FPG (laboratory analysis)(cf. Section 8.2.3) Key safety Endpoints •AEs (cf. Section 8.3.1) •Hypoglycaemic episodes (cf. Section 8.3.2) •Haematology (cf. Section 8.3.5) •Biochemistry (cf. Section 8.3.6) •Lipids (cf. Section 8.3.3) •Physical examination (cf. Section 8.3.8) •Vital signs (cf. Section 8.3.7) •CV risk markers (cf. section 8.3.4) | — |
Countries
Denmark, Finland, France, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed