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: July 3, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of subjects reaching HbA1c below 7.0% at Week 32

  • Fasting Plasma Glucose (FPG) at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Mean FPG at Week 10

  • Fasting Plasma Glucose (FPG) at Week 21 [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
    Mean FPG at Week 21

  • Fasting Plasma Glucose (FPG) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Estimated Mean FPG at Week 32

  • Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32

  • Body Weight at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Estimated mean body weight after 32 Weeks of treatment

  • Body Mass Index (BMI) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Estimated mean BMI after 32 Weeks of treatment

  • Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes) [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Scottsdale, Arizona, United States, 85251
United States, California
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
United States, Florida
Novo Nordisk Clinical Trial Call Center
Doral, Florida, United States, 33172
Novo Nordisk Clinical Trial Call Center
Hialeah, Florida, United States, 33012
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33313
Novo Nordisk Clinical Trial Call Center
Port Charlotte, Florida, United States, 33952
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30308-2253
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076-2126
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60616
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Springfield, Massachusetts, United States, 01199
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109-6001
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
United States, New York
Novo Nordisk Clinical Trial Call Center
New Windsor, New York, United States, 12553
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Beavercreek, Ohio, United States, 45432
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
Novo Nordisk Clinical Trial Call Center
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Clinical Trial Call Center
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75235-6233
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84102
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
Argentina
Buenos Aires, Argentina, C1449AAD
Brazil
São Paulo, Sao Paulo, Brazil, 01244-030
Canada, Alberta
Calgary, Alberta, Canada, T2N 4L7
France
Soulaines/Aubance, France, 49610
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Slovenia
Trbovlje, Slovenia, 1420
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Gitte S. Olesen, MSc Pharm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 3, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014