Comparación multinacional, abierta, aleatorizada, de grupos paralelos, con un periodo de prueba de 4 semanas y 26 semanas de tratamiento hasta conseguir el objetivo, de insulina aspart bifásica 30 una vez al día frente a insulina glargina una vez al día, ambas en combinación con metformina y con glimepirida, en pacientes con diabetes tipo 2 que no han recibido tratamiento con insulina

• Conditions: Diabetes tipo 2; MedDRA version: 9.1Level: LLTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitus

• Registration Number: EUCTR2006-003288-29-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-27
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified