Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
Conditions
Interventions
Trade Name: NovoMix 30 FlexPen 100 U/ml
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Insulin Aspart
Concentration unit: U/ml unit(s)/millilitre
Concentration number: 100-
Trade
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written 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.Male or female, age =18 years. 3.Type 2 diabetes treated with maximum three different types of OADs for more than 6 months. 4.Unchanged total daily dose of at least 1500 mg (850 mg for Asian subjects) metformin for at least two months. 5.Unchanged total daily dose of at least half maximum recommended daily dose of any insulin secretagogue for the last two months. 6.Insulin naïve. 7.If treatment with any lipid lowering drug, the treatment (dosage) must have been ongoing and unchanged for at least 2 months. 8.HbA1c = 7.0% and = 11.0%. 9.BMI = 40.0 kg/m2. 10.Able and willing to take 1 s.c. injection a day. 11.Able and willing to perform the mandatory SMPG measurements on consecutive days before the visits/phone contacts (weeks prior to Visits 4, 15, 19 and 22: one 9-point profile + additional pre-breakfast measurement; other weeks: three pre-breakfast measurements). 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 any of the trial products or related products. 2.Treatment with any thiazolidinedione (TZD) during the last 5 months before Visit 1 in this trial. 3.Known haemoglobinopathy or chronic anaemia or other blood disorder, metabolic or lactic acidosis, hypoxemia, dehydration or cancer (other than basal or squamous cell). 4.Cardiac disease, within the last 12 months, defined as: decompensated heart failure (NYHA class III or IV), unstable angina pectoris or myocardial infarction. 5.Impaired kidney function with serum creatinine = 135 µmol/L (1.5 mg/dL) for males and = 110 µmol/L (1.3 mg/dL) for females. 6.Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in the past 6 months. 7. Increased total cholesterol and/or LDL-cholesterol (LDL-C) level more than 2 times the upper reference limit. 8.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). 9.Proliferative retinopathy or maculopathy requiring acute treatment. 10.Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 11.Any disease or condition which the Investigator feels would interfere with the trial. 12.Systemic treatment with any corticosteroid 3 months prior to inclusion. 13.Use of any drug (except for OADs required to be included in this investigation), which in the Investigator’s opinion could interfere with glucose levels. 14.Previous treatment with insulin for more than 7 days. 15.The receipt of any investigational drug within 1 month prior to this trial. 16.Previous participation in this trial (participation defined as randomised).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if biphasic insulin aspart (BIAsp) 30 once daily (OD) in combination with metformin and glimepiride is non-inferior and superior in the event of non-inferiority, compared with insulin glargine OD in combination with both metformin and glimepiride with respect to glycaemic control, as measured by HbA1c after 26 weeks of treatment in subjects with type 2 diabetes, failing on oral anti-diabetic drugs (OADs).;Secondary Objective: •To compare the following parameters in the BIAsp 30 group with those in the glargine group, both in combination with metformin and glimepiride after 26 weeks treatment:•the glycaemic control as measured by 9-point PG profiles•the safety profile as measured by the incidence of hypoglycaemic episodes, AEs, laboratory tests and clinical evaluations•change in body weight•change in WC•total daily insulin dose•the percentage of subjects achieving the treatment target of HbA1c =6.5%•the percentage of subjects achieving the treatment target of HbA1c < 7.0%•the percentage of subjects achieving a HbA1c reduction of = 1.0 % from baseline•the prandial glucose increment over each of the 3 main meals•the average prandial glucose increments•the cardiovascular (CV) risk marker as measured by the lipid profile (total cholesterol, HDL, LDL, TG) and the high sensitive C-reactive protein (hs CRP)•Treatment Satisfaction as measured by the Diab MedSat questionnaire ;Primary end point(s): Primary efficacy endpoints •HbA1c | — |
Countries
Austria, Czech Republic, France, Netherlands, Spain, Sweden
Outcome results
None listed