DiabetesPhase 4Full STEP™NCT01165684
Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen
A Phase 4 study testing insulin aspart and insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 67 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart and insulin detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 67 sitesin 7 countries
- Study dates
- Oct 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
67 sites in 7 countries.
67 sites in 7 countries
United States33 sites
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Atlanta, Georgia, 30308-2253
Novo Nordisk Investigational Site
Beavercreek, Ohio, 45432
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Brooklyn Center, Minnesota, 55430
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Dallas, Texas, 75235-6233
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Mesa, Arizona, 85206
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Miami, Florida, 33165
Novo Nordisk Investigational Site
New Windsor, New York, 12553
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Plantation, Florida, 33313
Novo Nordisk Investigational Site
Port Charlotte, Florida, 33952
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
Scottsdale, Arizona, 85251
Novo Nordisk Investigational Site
Springfield, Massachusetts, 01199
Canada12 sites
Novo Nordisk Investigational Site
Calgary, Alberta, T2N 4L7
Novo Nordisk Investigational Site
Chatham, Ontario, N7L 1C1
Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Gatineau, Quebec, J8V 2P5
Novo Nordisk Investigational Site
Kingston, Ontario, K7L 2V7
Novo Nordisk Investigational Site
Lachine, Quebec, H8S 2E4
Novo Nordisk Investigational Site
Langley, British Columbia, V3A 4H9
Novo Nordisk Investigational Site
Mirabel, Quebec, J7J 2K8
Novo Nordisk Investigational Site
Montreal, Quebec, H2W 1R7
Novo Nordisk Investigational Site
Montreal, Quebec, H3T 1E2
Novo Nordisk Investigational Site
Vancouver, British Columbia, V5Z 1M9
Novo Nordisk Investigational Site
Victoria, British Columbia, V8V 3N7
Argentina7 sites
Novo Nordisk Investigational Site
Buenos Aires, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, B1704ETD
Novo Nordisk Investigational Site
Buenos Aires, C1250AAN
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
Caba, C1440AAD
Novo Nordisk Investigational Site
Córdoba, X5006IKK
Novo Nordisk Investigational Site
Mendoza, 5500
Brazil5 sites
Novo Nordisk Investigational Site
Campinas, 13084-971
Novo Nordisk Investigational Site
Goiânia, Goiás, 74043-011
Novo Nordisk Investigational Site
Porto Alegre, 90035-170
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, 20211-340
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01244-030
France5 sites
Novo Nordisk Investigational Site
Marseille, 13009
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Sète, 34200
Novo Nordisk Investigational Site
Vénissieux, 69200
Slovenia4 sites
Novo Nordisk Investigational Site
Brežice, 8250
Novo Nordisk Investigational Site
Kranj, 4000
Novo Nordisk Investigational Site
Novo Mesto, 8000
Novo Nordisk Investigational Site
Trbovlje, 1420
About this study
Official title: 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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin aspart, insulin detemir
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c.
Doses individually adjusted.
insulin aspartDrug
Insulin aspart added before each main meal. Doses individually adjusted.
insulin detemirDrug
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Step-wise | Experimental | Not described Receives: Drug: insulin aspart; Drug: insulin detemir |
| Basal-bolus | Active comparator | Not described Receives: Drug: insulin aspart; Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
Estimated mean change from baseline in HbA1c after 32 Weeks of treatment
Measured: Week 0, Week 32
Secondary outcomes (14)
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
Estimated mean change from baseline in HbA1c after 10 Weeks of treatment
Measured: Week 0, Week 10
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
Estimated mean change from baseline in HbA1c after 21 Weeks of treatment
Measured: Week 0, Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
Proportion of subjects reaching HbA1c below 7.0% at Week 10
Measured: Week 10
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
Proportion of subjects reaching HbA1c below 7.0% at Week 21
Measured: Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
Proportion of subjects reaching HbA1c below 7.0% at Week 32
Measured: Week 32
Fasting Plasma Glucose (FPG) at Week 10
Mean FPG at Week 10
Measured: Week 10
Fasting Plasma Glucose (FPG) at Week 21
Mean FPG at Week 21
Measured: Week 21
Fasting Plasma Glucose (FPG) at Week 32
Estimated Mean FPG at Week 32
Measured: Week 32
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10
Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10
Measured: Week 10
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21
Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21
Measured: Week 21
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32
Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32
Measured: Week 32
Body Weight at Week 32
Estimated mean body weight after 32 Weeks of treatment
Measured: Week 32
Body Mass Index (BMI) at Week 32
Estimated mean BMI after 32 Weeks of treatment
Measured: Week 32
Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.
Measured: Week 0 to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165684
- Sponsor's protocol ID
- ANA-3786
- Other IDs
- 2010-018974-19, U1111-1116-0908
- Acronym
- Full STEP™
- Status last verified
- Jan 2017
- First submitted
- 16 Jul 2010
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):30-7. doi: 10.1016/S2213-8587(13)70090-1. Epub 2013 Sep 25.
PubMed 24622667
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01165684
- Acronym / sponsor ID
- Full STEP™ / ANA-3786
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Posted 11 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step-wise | Experimental | Drug: insulin aspart, Drug: insulin detemir |
| Basal-bolus | Active comparator | Drug: insulin aspart, Drug: insulin detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin aspartInsulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted. | Drug | Step-wise |
| insulin aspartInsulin aspart added before each main meal. Doses individually adjusted. | Drug | Basal-bolus |
| insulin detemirInsulin detemir as basal insulin, adminstered once daily. Doses individually adjusted. | Drug | Basal-bolus, Step-wise |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
Time frame: Week 0, Week 32
Estimated mean change from baseline in HbA1c after 32 Weeks of treatment
14 secondary outcomes
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
Time frame: Week 0, Week 10
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
Time frame: Week 0, Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
Time frame: Week 10
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
Time frame: Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
Time frame: Week 32
Fasting Plasma Glucose (FPG) at Week 10
Time frame: Week 10
Fasting Plasma Glucose (FPG) at Week 21
Time frame: Week 21
Fasting Plasma Glucose (FPG) at Week 32
Time frame: Week 32
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10
Time frame: Week 10
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21
Time frame: Week 21
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32
Time frame: Week 32
Body Weight at Week 32
Time frame: Week 32
Body Mass Index (BMI) at Week 32
Time frame: Week 32
Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)
Time frame: Week 0 to Week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24622667Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):30-7. doi: 10.1016/S2213-8587(13)70090-1. Epub 2013 Sep 25.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
67 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin aspart and insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 67 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, Argentina, Brazil, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32 (time frame: Week 0, Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.