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

Diabetes Mellitus, Type 2 Clinical Trial

— BOOST™  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045447
• Other study ID #: NN5401-3593
• Secondary ID: U1111-1111-72262
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2010
• Last updated: October 19, 2015
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social CareFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)South Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyUnited States: Food and Drug AdministrationIndia: Ministry of HealthTurkey: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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 degludec/insulin aspart
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
• insulin glargine
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Albany	New York
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Austin	Texas
United States	Novo Nordisk Clinical Trial Call Center	Baltimore	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Boynton Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	Clearwater	Florida
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Nashua	New Hampshire
United States	Novo Nordisk Clinical Trial Call Center	New Port Richey	Florida
United States	Novo Nordisk Clinical Trial Call Center	Orlando	Florida
United States	Novo Nordisk Clinical Trial Call Center	Pembroke Pines	Florida
United States	Novo Nordisk Clinical Trial Call Center	Southfield	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Southfield	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Statesville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida
United States	Novo Nordisk Clinical Trial Call Center	Waltham	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Croatia,  France,  India,  Korea, Republic of,  Poland,  South Africa,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 26 weeks of treatment.	Week 0, Week 26	No
Secondary	Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.	Week 26	No

External Links

•   Clinical Trials at Novo Nordisk