A randomised, controlled, open label, multicentre, multinational, treat-to-target trial investigating the efficacy and safety of intensification with addition of bolus insulin aspart in subjects with type 2 diabetes inadequately controlled on basal insulin with or without oral anti-diabetic drugs: Step-wise addition versus complete basal-bolus therapy - Full STEP™

• Conditions: Type 2 Diabetes; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-018974-19-SI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-13
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 848

Inclusion Criteria

• Male or female =18 years of age
• Type 2 diabetes (diagnosed clinically) for =12 months
• Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) = 6 months
• HbA1c 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (Visit 1)
• Use of GLP-1 receptor agonists or pramlintide within the last 6 months prior to screening visit (Visit 1)
• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, MAO inhibitors, etc.)
• Cardiovascular disease, within the last 12 months prior to screening visit (Visit 1), defined as: 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.
• Uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting = 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg). For Argentina: systolic blood pressure sitting = 150 mmHg and/or diastolic blood pressure = 90 mmHg
• Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive).
• Impaired renal function defined as serum creatinine >135 µmol/L (>1.5 mg/dL) for males and >110 µmol/L ( >1.2 mg/dL) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula). One retest within a week is permitted with the result of the last sample being conclusive.
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months.
• Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
• Treatment with OADs contraindicated or unapproved for combination treatment with insulin (according to local OAD label)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change in HbA1c from baseline to week 32/end of trial;Main Objective: The primary objective of this trial is to confirm efficacy of step-wise addition of bolus insulin in terms of glycaemic control assessed by change in HbA1c. This is done by comparing the difference in change from baseline in HbA1c after 32 weeks of treatment/end of trial between step-wise addition of bolus insulin versus complete basal-bolus therapy using a non-inferiority approach.;Secondary Objective: • To assess and compare efficacy in terms of:<br> Fasting plasma glucose (FPG) values<br> 7-point Self Measured Plasma Glucose (SMPG) Profile<br>• To assess and compare safety and tolerability in terms of:<br> Hypoglycaemic episodes<br> Adverse events<br> Clinical and laboratory assessments<br> Change in body weight and body mass index (BMI)