A 26-week trial comparing efficacy and safety of insulin degludec/insulin aspart BID and insulin degludec OD plus insulin aspart in subjects with type 2 Diabetes Mellitus treated with basal insulin in need of treatment intensification with mealtime insuli

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-002346-20-AT
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Male or female = 18 years of age
2. Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for = 26 weeks prior to screening (visit 1)
3. Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, a-glucosidase-inhibitors
4. HbA1c 7.0% - 10.0%
5. Body mass index (BMI) = 40.0 kg/m^2
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 202
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

1. Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
2. Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
3. Chronic disorder or disease which might jeopardise safety or compliance
4. Malignant neoplasms
5. Recurrent severe hypoglycaemia

Study & Design

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