CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 465 enrolled
Drug / intervention
insulin degludec/insulin aspart +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01045447
NCT01045447Phase 3Completed
CompareCT.gov

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)

Novo Nordisk A/S·interventional·Posted Jan 11, 2010·Updated Mar 20, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 465 participants across 65 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCroatia, France, India, Poland, South Africa, South Korea, Sweden, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2010
Enrollment StartJan 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.5 years ago

Interventions

insulin degludec/insulin aspartdrug

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

insulin glarginedrug

Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.