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Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

NCT01045447•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
•Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn \[NPH\] insulin) once daily (OD), for at least 3 months
•Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
•BMI maximum 40.0 kg/m\^2

Exclusion Criteria

•Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
•Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
•Current rosiglitazone users
•Cardiovascular disease, within the last 6 months prior to 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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
•Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
•Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
•Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Locations (65)

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Waterbury, Connecticut, United States

Novo Nordisk Investigational Site

Boynton Beach, Florida, United States

Novo Nordisk Investigational Site

Clearwater, Florida, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Novo Nordisk Investigational Site

New Port Richey, Florida, United States

Novo Nordisk Investigational Site

Orlando, Florida, United States

Novo Nordisk Investigational Site

Pembroke Pines, Florida, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

March 20, 2017

Enrollment

465

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspart

DRUG

insulin glargine

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: March 20, 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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