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: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-002346-20-NO
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-06
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to confirm the efficacy of IDegAsp BID in controlling glycaemia after 26 weeks of treatment. This is done by comparing the difference in change in glycosylated haemoglobin (HbA1c) between IDegAsp BID ± OADs and IDeg OD plus IAsp 2-4 times daily ± OADs to a non-inferiority limit of 0.4%, in accordance with draft Guidance for Industry Diabetes Mellitus, Food and Drug Administration (FDA) 2008;Secondary Objective: The secondary objective is to compare other efficacy, safety and patient reported outcome (PRO) parameters of IDegAsp BID ±OADs versus IDeg OD + mealtime IAsp (2-4 times daily) ± OADs;Primary end point(s): Change from baseline in HbA1c (%) ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment<br>2.-3. During 26 weeks of treatment<br><br>;Secondary end point(s): 1. Change from baseline in fasting plasma glucose (FPG)<br>2. Hypoglycaemia: <br>- Number of treatment emergent hypoglycaemic episodes both according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) < 3.1 mmol/L(56 mg/dL) as well as to the ADA definition <br>- Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes<br>3. Incidence of treatment emergent adverse events (TEAE)