A trial comparing efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in insulin naïve subjects with type 2 diabetes

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-001712-61-BG
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-03
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

- 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.)
- Male or female = 18 years of age
- Type 2 diabetes mellitus (diagnosed clinically) for = 24 weeks

- Current treatment: metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPPIV) inhibitor, a-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated:
- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily)
- Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling
- DPP-IV inhibitor: minimum 100 mg daily or according to local labelling
- a-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose

- Insulin naïve subject; allowed is:
- Previous short term insulin treatment up to 14 days
- Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body mass index (BMI) = 40.0 kg/m2
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 319
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

- Treatment with thiazolidinedione (TZDs) or GLP-1 receptor agonists within 12 weeks prior to Visit 1
- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
- Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- Cardiovascular disease, within the last 24 weeks prior to visit 1, defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
- Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
- Known or suspected hypersensitivity to trial products or related products

Study & Design

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