CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 296 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/NCT01272193
NCT01272193Phase 3Completed
CompareCT.gov

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

Novo Nordisk A/S·interventional·Posted Jan 7, 2011·Updated Mar 17, 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 296 participants across 50 sites.

Detailed Summary

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartJan 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.5 years ago

Interventions

insulin degludec/insulin aspartdrug

Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).

insulin glarginedrug

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.