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Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen | Clinical Trials | Clareo Health

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

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

NCT01165684•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

Locations (67)

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Novo Nordisk Investigational Site

Mesa, Arizona, United States

Novo Nordisk Investigational Site

Scottsdale, Arizona, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Hialeah, Florida, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Novo Nordisk Investigational Site

Miami, Florida, United States

Novo Nordisk Investigational Site

Miami, Florida, United States

Novo Nordisk Investigational Site

Plantation, Florida, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

February 17, 2017

Enrollment

401

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin aspart

DRUG

insulin aspart

DRUG

insulin detemir

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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