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

Diabetes Mellitus, Type 2 Clinical Trial

— Full STEP™  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165684
• Other study ID #: ANA-3786
• Secondary ID: 2010-018974-19U1
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2010
• Last updated: March 17, 2015
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaBrazil: National Health Surveillance AgencyCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of MacedoniaSlovenia: Agency of Drugs and Medicinal Products of the Slovenian RepublicUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin aspart
Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted.
• insulin aspart
Insulin aspart added before each main meal. Doses individually adjusted.
• insulin detemir
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Beavercreek	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Birmingham	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Brooklyn Center	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Doral	Florida
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Hialeah	Florida
United States	Novo Nordisk Clinical Trial Call Center	Indianapolis	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Kettering	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	New Windsor	New York
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Plantation	Florida
United States	Novo Nordisk Clinical Trial Call Center	Port Charlotte	Florida
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Salt Lake City	Utah
United States	Novo Nordisk Clinical Trial Call Center	Salt Lake City	Utah
United States	Novo Nordisk Clinical Trial Call Center	Scottsdale	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Springfield	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Tipton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Macedonia, The Former Yugoslav Republic of,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10	Estimated mean change from baseline in HbA1c after 10 Weeks of treatment	Week 0, Week 10	No
Secondary	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21	Estimated mean change from baseline in HbA1c after 21 Weeks of treatment	Week 0, Week 21	No
Secondary	Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10	Proportion of subjects reaching HbA1c below 7.0% at Week 10	Week 10	No
Secondary	Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21	Proportion of subjects reaching HbA1c below 7.0% at Week 21	Week 21	No
Secondary	Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32	Proportion of subjects reaching HbA1c below 7.0% at Week 32	Week 32	No
Secondary	Fasting Plasma Glucose (FPG) at Week 10	Mean FPG at Week 10	Week 10	No
Secondary	Fasting Plasma Glucose (FPG) at Week 21	Mean FPG at Week 21	Week 21	No
Secondary	Fasting Plasma Glucose (FPG) at Week 32	Estimated Mean FPG at Week 32	Week 32	No
Secondary	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	Week 10	No
Secondary	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	Week 21	No
Secondary	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	Week 32	No
Secondary	Body Weight at Week 32	Estimated mean body weight after 32 Weeks of treatment	Week 32	No
Secondary	Body Mass Index (BMI) at Week 32	Estimated mean BMI after 32 Weeks of treatment	Week 32	No
Secondary	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.	Week 0 to Week 32	No

External Links

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