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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin aspart Insulin detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: week 0, week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HbA1c - all subjects [ Time Frame: week 10, week 21 ] [ Designated as safety issue: No ]
Percentage of subjects reaching HbA1c below 7.0% [ Time Frame: week 10, week 21, week 32 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose [ Time Frame: week 10, week 21, week 32 ] [ Designated as safety issue: No ]
Change in mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) [ Time Frame: week 10, week 21, week 32 ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: week 0, week 32 ] [ Designated as safety issue: No ]
Change in BMI (Body Mass Index) [ Time Frame: week 0, week 32 ] [ Designated as safety issue: No ]
Hypoglycaemic episodes (summarised by number of subjects, number of episodes and rate) [ Time Frame: week -9 to week 22 ] [ Designated as safety issue: No ]

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: A	Drug: insulin aspart Insulin detemir as basal insulin and insulin aspart added stepwise according to the largest meal. Doses individually adjusted Drug: insulin detemir Insulin detemir as basal insulin and insulin aspart added stepwise according to the largest meal. Doses individually adjusted
Active Comparator: B	Drug: insulin aspart Insulin detemir as basal insulin and full basal-bolus therapy with insulin aspart added before each main meal. Doses individually adjusted Drug: insulin detemir Insulin detemir as basal insulin and full basal-bolus therapy with insulin aspart added before each main meal. 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 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)
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 trial start)
Use of GLP-1 (Glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to trial start
Cardiovascular disease within the last 12 months prior to trial start
Uncontrolled treated/untreated severe hypertension
Impaired liver function
Impaired kidney function
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the physician or hospitalisation for diabetic ketoacidosis during the previous 6 months
Proliferative retinopathy or maculopathy requiring treatment according to the physician
Treatment with OADs (oral antidiabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local OAD label)

Contacts and Locations

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

Show 39 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Gitte S. Olesen, MSc Pharm

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, 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
Last Updated:	April 26, 2012
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 aspart

Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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