A randomised trial comparing efficacy and safety after intensification with either insulin aspart once daily as add-on or changing to basal bolus treatment with insulin degludec and insulin aspart in subjects with type 2 diabetes previously treated with insulin degludec/insulin aspart twice daily

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: EUCTR2012-003152-37-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 97

Inclusion Criteria

HbA1c = 7.0% measured after 26 weeks of treatment in NN5401-3941, by central laboratory analysis
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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Uncontrolled or untreated severe hypertension defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg
- Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) = 2.5 times upper limit of normal
- Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) vs. basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c);Secondary Objective: The secondary objectives are to compare:<br>- Safety of IDegAsp BID + IAsp OD vs. basal bolus with IDeg OD + IAsp TID<br>- Efficacy in terms of other measures of glycaemic control;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
Secondary end point(s): Safety endpoints:<br>1. Incidence of treatment emergent adverse events (TEAEs) <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 American Diabetes Association (ADA) definition <br>- Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes <br><br>Efficacy endpoint:<br>3. Change from baseline in fasting plasma glucose (FPG) ;Timepoint(s) of evaluation of this end point: Safety endpoints:<br>1.-2. During 26 weeks of treatment<br><br>Efficacy endpoints:<br>3. After 26 weeks of treatment