MedDataX Logo

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

NCT ID: NCT01165684

Last Updated: 2017-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mylan Insulin Aspart Study

NCT03760068

Diabetes Mellitus, Type 1
COMPLETED PHASE3

Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

NCT00331604

Diabetes Diabetes Mellitus, Type 2
TERMINATED PHASE3

A Research Study of a New Medicine NNC0113-6856 in Healthy Males

NCT05521256

Healthy Volunteers Type 2 Diabetes
COMPLETED PHASE1

A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus

NCT04655690

Diabetes Mellitus, Type 1
COMPLETED PHASE1

Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

NCT00309244

Diabetes Type 2
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Step-wise

Group Type EXPERIMENTAL

insulin aspart

Intervention Type DRUG

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

Doses individually adjusted.

insulin detemir

Intervention Type DRUG

Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Basal-bolus

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

Insulin aspart added before each main meal. Doses individually adjusted.

insulin detemir

Intervention Type DRUG

Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin aspart

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

Doses individually adjusted.

Intervention Type DRUG

insulin aspart

Insulin aspart added before each main meal. Doses individually adjusted.

Intervention Type DRUG

insulin detemir

Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Mesa, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Scottsdale, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

Hialeah, Florida, United States

Site Status

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Site Status

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Plantation, Florida, United States

Site Status

Novo Nordisk Investigational Site

Port Charlotte, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Metairie, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Rockville, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Springfield, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Brooklyn Center, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Jefferson City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Site Status

Novo Nordisk Investigational Site

Lawrenceville, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

New Windsor, New York, United States

Site Status

Novo Nordisk Investigational Site

Beavercreek, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Dayton, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Kettering, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Altoona, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Greer, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Salt Lake City, Utah, United States

Site Status

Novo Nordisk Investigational Site

Salt Lake City, Utah, United States

Site Status

Novo Nordisk Investigational Site

Newport News, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Caba, , Argentina

Site Status

Novo Nordisk Investigational Site

Córdoba, , Argentina

Site Status

Novo Nordisk Investigational Site

Mendoza, , Argentina

Site Status

Novo Nordisk Investigational Site

Goiânia, Goiás, Brazil

Site Status

Novo Nordisk Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Novo Nordisk Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Novo Nordisk Investigational Site

Campinas, , Brazil

Site Status

Novo Nordisk Investigational Site

Porto Alegre, , Brazil

Site Status

Novo Nordisk Investigational Site

Calgary, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Coquitlam, British Columbia, Canada

Site Status

Novo Nordisk Investigational Site

Langley, British Columbia, Canada

Site Status

Novo Nordisk Investigational Site

Vancouver, British Columbia, Canada

Site Status

Novo Nordisk Investigational Site

Victoria, British Columbia, Canada

Site Status

Novo Nordisk Investigational Site

Chatham, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Kingston, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Gatineau, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Lachine, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Mirabel, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Marseille, , France

Site Status

Novo Nordisk Investigational Site

Narbonne, , France

Site Status

Novo Nordisk Investigational Site

Saint-Herblain, , France

Site Status

Novo Nordisk Investigational Site

Sète, , France

Site Status

Novo Nordisk Investigational Site

Vénissieux, , France

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Brežice, , Slovenia

Site Status

Novo Nordisk Investigational Site

Kranj, , Slovenia

Site Status

Novo Nordisk Investigational Site

Novo Mesto, , Slovenia

Site Status

Novo Nordisk Investigational Site

Trbovlje, , Slovenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Brazil Canada France North Macedonia Slovenia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 24622667 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-018974-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1116-0908

Identifier Type: OTHER

Identifier Source: secondary_id

ANA-3786

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes
NCT00400283 COMPLETED PHASE1
Comparison of Thrice-Daily Premixed Human Insulin with Basal-Bolus Therapy Among Patients with Poorly Controlled Type 2 Diabetes Mellitus
NCT06855615 COMPLETED PHASE4
Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
NCT00765817 COMPLETED PHASE3
Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes
NCT00427154 TERMINATED PHASE3
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes
NCT00725036 COMPLETED PHASE3
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
NCT00523042 TERMINATED PHASE3
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
NCT06542874 COMPLETED PHASE2
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
NCT01445951 COMPLETED PHASE3
A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes
NCT01999322 COMPLETED PHASE3
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
NCT04569994 COMPLETED PHASE1
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
NCT03143816 COMPLETED PHASE4
INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes
NCT01087567 COMPLETED PHASE4
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
NCT04538352 COMPLETED PHASE4
Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes
NCT00355849 COMPLETED PHASE3
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
NCT01652716 COMPLETED PHASE3
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
NCT01003184 COMPLETED PHASE3
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
NCT00424437 COMPLETED PHASE3
To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension
NCT00790153 COMPLETED PHASE1
Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes
NCT00437112 COMPLETED PHASE3
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
NCT00111540 COMPLETED PHASE3
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
NCT00472953 TERMINATED PHASE3
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
NCT01194258 COMPLETED PHASE2
Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
NCT00325364 COMPLETED PHASE3
GALLANT 4 Tesaglitazar vs. Glibenclamide
NCT00255541 TERMINATED PHASE3
A Study for Patients With Type 2 Diabetes Mellitus
NCT00490854 COMPLETED PHASE2/PHASE3