NCT01165684|CompletedPhase 4Results

Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen

Full STEP™

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

ANA-37862010-018974-19U1111-1116-0908

Study Type

interventional

Target

401

Locations

7 countries

Sites

Timeline

RegisteredJul 2010

StartedOct 2010

CompletionApr 2012

Brief Summary

This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

401

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Oct 2010

Geographic Reach

7 countries

67 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

July 16, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2013

Completed

Last Updated

February 17, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

July 16, 2010

Results QC Date

April 25, 2013

Last Update Submit

January 2, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
Estimated mean change from baseline in HbA1c after 32 Weeks of treatment
Week 0, Week 32

Secondary Outcomes (14)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
Week 0, Week 10
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
Week 0, Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
Week 10
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
Week 32
+9 more secondary outcomes

Study Arms (2)

Step-wise

EXPERIMENTAL

Drug: insulin aspartDrug: insulin detemir

Basal-bolus

ACTIVE COMPARATOR

Drug: insulin aspartDrug: insulin detemir

Interventions

insulin aspartDRUG

Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted.

Step-wise

insulin detemirDRUG

Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Basal-bolusStep-wise

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes (diagnosed clinically) for at least 12 months
Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 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 (Body Mass Index) less than 40.0 kg/m\^2

You may not qualify if:

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 (Glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to 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 (Monoamine oxidase) 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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg). For Argentina: systolic blood pressure sitting at least 150 mmHg and/or diastolic blood pressure at least 90 mmHg
Impaired liver function, defined as ALAT (Alanine aminotransferase) at least 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 above 135 micromol/L (above 1.5 mg/dL) for males and above 110 micromol/L (above 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 (Oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local OAD label)

Contact the study team to confirm eligibility.