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Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen (Full STEP™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01165684
First received: July 16, 2010
Last updated: January 2, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin aspart
Drug: insulin detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10 [ Time Frame: Week 0, Week 10 ]
    Estimated mean change from baseline in HbA1c after 10 Weeks of treatment

  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21 [ Time Frame: Week 0, Week 21 ]
    Estimated mean change from baseline in HbA1c after 21 Weeks of treatment

  • Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10 [ Time Frame: Week 10 ]
    Proportion of subjects reaching HbA1c below 7.0% at Week 10

  • Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21 [ Time Frame: Week 21 ]
    Proportion of subjects reaching HbA1c below 7.0% at Week 21

  • Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32 [ Time Frame: Week 32 ]
    Proportion of subjects reaching HbA1c below 7.0% at Week 32

  • Fasting Plasma Glucose (FPG) at Week 10 [ Time Frame: Week 10 ]
    Mean FPG at Week 10

  • Fasting Plasma Glucose (FPG) at Week 21 [ Time Frame: Week 21 ]
    Mean FPG at Week 21

  • Fasting Plasma Glucose (FPG) at Week 32 [ Time Frame: Week 32 ]
    Estimated Mean FPG at 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 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 21

  • Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32 [ Time Frame: Week 32 ]
    Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32

  • Body Weight at Week 32 [ Time Frame: Week 32 ]
    Estimated mean body weight after 32 Weeks of treatment

  • Body Mass Index (BMI) at Week 32 [ Time Frame: Week 32 ]
    Estimated mean BMI after 32 Weeks of treatment

  • Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes) [ Time Frame: Week 0 to Week 32 ]
    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.


Enrollment: 401
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Step-wise Drug: insulin aspart

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

Doses individually adjusted.

Drug: insulin detemir
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.
Active Comparator: Basal-bolus Drug: insulin aspart
Insulin aspart added before each main meal. Doses individually adjusted.
Drug: insulin detemir
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165684

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85206
Novo Nordisk Investigational Site
Scottsdale, Arizona, United States, 85251
United States, California
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
United States, Florida
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33012
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32204
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
Novo Nordisk Investigational Site
Miami, Florida, United States, 33165
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33313
Novo Nordisk Investigational Site
Port Charlotte, Florida, United States, 33952
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30308-2253
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60616
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Springfield, Massachusetts, United States, 01199
United States, Minnesota
Novo Nordisk Investigational Site
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
Novo Nordisk Investigational Site
New Windsor, New York, United States, 12553
United States, Ohio
Novo Nordisk Investigational Site
Beavercreek, Ohio, United States, 45432
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75235-6233
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1704ETD
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1250AAN
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425AGC
Novo Nordisk Investigational Site
Caba, Argentina, C1440AAD
Novo Nordisk Investigational Site
Córdoba, Argentina, X5006IKK
Novo Nordisk Investigational Site
Mendoza, Argentina, 5500
Brazil
Novo Nordisk Investigational Site
Goiania, Goias, Brazil, 74043-011
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 01244-030
Novo Nordisk Investigational Site
Campinas, Brazil, 13084-971
Novo Nordisk Investigational Site
Porto Alegre, Brazil, 90035-170
Novo Nordisk Investigational Site
Rio de Janeiro, Brazil, 20211-340
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2N 4L7
Canada, British Columbia
Novo Nordisk Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Novo Nordisk Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Novo Nordisk Investigational Site
Victoria, British Columbia, Canada, V8V 3N7
Canada, Ontario
Novo Nordisk Investigational Site
Chatham, Ontario, Canada, N7L 1C1
Novo Nordisk Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
Novo Nordisk Investigational Site
Gatineau, Quebec, Canada, J8V 2P5
Novo Nordisk Investigational Site
Lachine, Quebec, Canada, H8S 2E4
Novo Nordisk Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H2W 1R7
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H3T 1E2
France
Novo Nordisk Investigational Site
Marseille, France, 13009
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
Saint Herblain, France, 44800
Novo Nordisk Investigational Site
Sète, France, 34200
Novo Nordisk Investigational Site
Venissieux, France, 69200
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Slovenia
Novo Nordisk Investigational Site
Brezice, Slovenia, 8250
Novo Nordisk Investigational Site
Kranj, Slovenia, 4000
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Novo Nordisk Investigational Site
Trbovlje, Slovenia, 1420
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01165684     History of Changes
Other Study ID Numbers: ANA-3786  2010-018974-19  U1111-1116-0908 
Study First Received: July 16, 2010
Results First Received: April 25, 2013
Last Updated: January 2, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Detemir
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017