Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes (BOOST™)
|ClinicalTrials.gov Identifier: NCT01045447|
Recruitment Status : Completed
First Posted : January 11, 2010
Results First Posted : November 18, 2015
Last Update Posted : March 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/insulin aspart Drug: insulin glargine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||465 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2010|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
|Experimental: IDegAsp OD||
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.
|Active Comparator: IGlar OD||
Drug: insulin glargine
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
- Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]Change from baseline in HbA1c after 26 weeks of treatment.
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 26 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045447
Show 65 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|