CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 272 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/NCT01680341
NCT01680341Phase 3Completed
CompareCT.gov

A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

Novo Nordisk A/S·interventional·Posted Sep 7, 2012·Updated Apr 2, 2018

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 272 participants across 45 sites in 5 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAlgeria, Germany, Malaysia, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartAug 31, 2012
Primary CompletionAug 22, 2013
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 13.8 years ago

Interventions

insulin degludec/insulin aspartdrug

Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.

insulin degludec/insulin aspartdrug

Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.